DePuy Synthes Mitek Vapr 3
DePuy Synthes · Model Mitek Vapr 3
Protection of arthroscopic equipment from damage caused by proximity of radiofrequency energy. Optimized and safe performance for various electrode types without the need to manually adjust the settings. Flexibility and enhanced safety by adjusted ablation speed and depth of tissue effect based on anatomical area and individual patient factors.
Key tips
- ·Never defeat or bypass a return-electrode monitoring (REM) alarm to finish a case - it's a direct burn risk.
- ·Verify OR table battery backup - a table that loses power mid-procedure is a real, documented incident type.
- ·Track surgical light lamp-hours rather than waiting for failure - a sudden failure mid-case is avoidable.
Typical Failure Modes
Compiled for this model from its own documentation and established engineering knowledge for this equipment class - not from a verified service record. Confirm against the manufacturer's service manual.
No or low RF output / high-impedance cut-out
HighSymptoms: No cut / coag effect, "high impedance" or output-error message, output shuts down.
Root cause: Poor electrode contact or a dry field, a damaged handpiece / cable, a return-electrode (REM/NESSY) fault, or an output-stage fault.
Return-electrode (patient-plate) contact-quality alarm
MediumSymptoms: REM / NESSY / plate alarm, monopolar output inhibited.
Root cause: Poorly applied or dried split dispersive pad, a pad-cable fault, or the contact-quality-monitor circuit.
Bipolar / vessel-sealing output fault
MediumSymptoms: Bipolar or sealing output weak, seal cycle will not complete, instrument not recognised.
Root cause: Bipolar cable / instrument fault or the sealing output stage.
Fails calibration / output drifts after a repair
MediumSymptoms: Output power or the REM circuit outside tolerance on the analyser.
Root cause: Output board or REM circuit needs recalibration - anti-static handling required.
Footswitch / handswitch fault
MediumSymptoms: Output will not activate from the pedal or the handpiece.
Root cause: Footswitch or handswitch / cable fault.
Touchscreen / display / boot fault
LowSymptoms: Unresponsive touchscreen, will not power on or boot, fan / thermal alarm.
Root cause: Display, power supply, control board, or a cooling-fan fault.
Serviceable Parts & Consumables
Serviceable items for this model, compiled from its documentation and engineering knowledge for this equipment class. Service class and relative cost are estimates, not manufacturer figures; no part numbers are given. Confirm intervals and pricing against the manufacturer.
Reusable instrument / handpiece cables
Class Periodic replacementRel. cost $$R&R Easy
Split dispersive (return) pads
Class ConsumableRel. cost $R&R Easy
Footswitch
Class Periodic replacementRel. cost $$R&R Fairly easy
Bipolar / sealing cable
Class Periodic replacementRel. cost $$R&R Easy
RF output board
Recalibration required after replacement; anti-static handling.
Class Major service partRel. cost $$$$R&R Difficult
Cooling fan
Class Major service partRel. cost $R&R Moderate
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Reusable instrument / handpiece cables | Periodic replacement | $$ | Easy |
| Split dispersive (return) pads | Consumable | $ | Easy |
| Footswitch | Periodic replacement | $$ | Fairly easy |
| Bipolar / sealing cable | Periodic replacement | $$ | Easy |
| RF output board Recalibration required after replacement; anti-static handling. | Major service part | $$$$ | Difficult |
| Cooling fan | Major service part | $ | Moderate |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
PM Checklist
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
- ·Pre-case functional check
- ·Electrosurgical return-electrode cable inspection
- ·Table hydraulic / mechanical inspection
- ·Annual electrical safety test and full PM
Troubleshooting Approach
A starting sequence for this model, compiled from its documentation and engineering knowledge for this equipment class. Follow the manufacturer's service documentation for the actual procedure.
Symptom: No or low RF output / high impedance
- Confirm good electrode-tissue contact and an adequately wetted field.
- Inspect the handpiece / instrument and cable for damage; substitute known-good.
- Check the split dispersive pad is well applied with full skin contact and a good cable.
- Verify output into a resistive test load with an electrosurgical analyser.
- Replace the output board and recalibrate if output is confirmed absent (anti-static workplace).
Symptom: Return-electrode / plate alarm
- Re-apply a fresh split dispersive pad with full skin contact over well-perfused muscle.
- Check the pad cable and connector.
- Try a known-good pad.
- Run the contact-quality-monitor calibration if it still alarms with a good pad.
- Do calibration on a non-conductive surface.
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- Operating rooms
- Procedure rooms
- Interventional suites
Documents & Manuals
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- RECALL
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- RECALL
IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
- RECALL
Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product.
- RECALL
The device has an offset in the design that results in a reading approximately 3.2mm shorter than the actual length of the bone hole.
- RECALL
Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw
- RECALL
Products were made outside of Quality System Regulation, and potentially outside of premarket submission (510k/PMA) for certain devices. The safety or effectiveness of these devices cannot be assured.
- RECALL
Mitek identified that on VAPR Tripolar 90 Degree Suction Electrode the ablation and coagulation buttons are colored incorrectly. The wiring for each button function was confirmed as correct and the non-conformance impacted button color only
- RECALL
Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-contamination
- RECALL
Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration.
- RECALL
Specific units of the DePuy Mitek Sterile Reamers are not labeled correctly, 7 units were labeled as 11MM while the box actually contained a 10 MM reamer
- RECALL
Product may have wrong large product identification label with symbols on the box indicating a S90 VAPR Electrode instead of the VAPR 3.5 hook electrode
- RECALL
Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair
- RECALL
Incorrect suture configuration
- RECALL
Quick Disconnect Ratchet Handle may slip up the driver shaft or disengage leaving the shaft in the screw head.
- RECALL
Metal debris in the shaft component of the device
- RECALL
Product sterility may be compromised due to breach in sterile packaging
- RECALL
Product does not meet the required packaging specifications for pouch seal integrity which could lead to a breach in sterility
- RECALL
The inserter shafts bend, as they were manufactured with a different stainless steel than specified.
- RECALL
The device may contain one strand of suture instead of two strands
- RECALL
Mislabeled: The kit contained the incorrect Ligament Passer. The package contained a 9.5 mm instead of the labeled 11.5mm ligament passer
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