Boston Scientific ORISE ProKnife
Boston Scientific · Model ORISE ProKnife
GelFITT™ Technology Designed for Focal Injection Through the Tip of the electrode with the ORISE Gel viscous submucosal lifting agent. The only electrosurgical knife available approved for use with ORISE Gel viscous submucosal lifting agent. ORISE Gel is designed to provide a long-lasting mucosal elevation. Electrode T-shaped Electrode – Designed for cutting performance and precision with safety and procedural efficiency in mind. Small diameter electrode shaft – The 0.5mm diameter of the T-shaped electrode has a high current density, designed for precision. Secured Electrode length – The locking feature secures the electrode in place to ensure a fixed length of the electrode throughout the entire procedure, even in tortuous anatomy. Designed for Efficiency The locking feature allows the assistant to free their hands during the resection. ORISE™ ProKnife is available in a convenient procedure kit with ORISE Gel and 23ga Interject Injection Therapy Needle Catheter.
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
Failure patterns typical of this equipment class - general BMET reference, not verified against this exact unit's own service history unless flagged. Severity is a category-level estimate.
Instrument / implant breakage
HighSymptoms: Fractured tip, loose component, debris.
Root cause: Metal fatigue, improper reprocessing, or misuse.
Reprocessing / sterilization failure
MediumSymptoms: Residue, bioburden, discoloration.
Root cause: Inadequate cleaning cycle or damaged tray.
Table hydraulic / actuator fault
MediumSymptoms: Slow or drifting positioning.
Root cause: Cylinder seal or actuator wear.
OR light LED failure
LowSymptoms: Dim or dead panel, color shift.
Root cause: LED module aging.
Serviceable Parts & Consumables
The parts a BMET typically services on this class of equipment. Service class and relative cost are general engineering estimates for the category, not figures from this unit's documentation. Part numbers appear only when pulled from this unit's own service manual. Always confirm intervals and pricing against the manufacturer.
Table hydraulic actuator
Class Periodic replacementRel. cost $$$R&R Difficult
Instrument repair / replacement set
High-turnover consumable instruments.
Class Periodic replacementRel. cost $$R&R Fairly easy
Electrosurgical pencil & electrode
Consumable per procedure.
Class ConsumableRel. cost $R&R Easy
Return electrode (patient plate)
Single-use; expiry critical.
Class ConsumableRel. cost $R&R Easy
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Table hydraulic actuator | Periodic replacement | $$$ | Difficult |
| Instrument repair / replacement set High-turnover consumable instruments. | Periodic replacement | $$ | Fairly easy |
| Electrosurgical pencil & electrode Consumable per procedure. | Consumable | $ | Easy |
| Return electrode (patient plate) Single-use; expiry critical. | Consumable | $ | Easy |
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 structured starting point derived from the failure modes above. Follow the manufacturer's service documentation for the actual procedure.
Symptom: Electrosurgical electrode wear
- Confirm the presentation - typically poor cut/coag, sparking, low power - and note the exact alarm or message and the conditions when it occurs.
- Check the most likely cause first: burned/eroded blade or pencil.
- Isolate the affected subsystem using the manufacturer's functional check or self-test, where one is provided.
- If the fault is confirmed and not a field adjustment, service or replace the electrosurgical pencil & electrode per the manufacturer's service documentation.
- Return the device to service only after the manufacturer's functional and applicable electrical-safety checks pass.
- Record the findings, any parts used, and the verification results in the maintenance history.
Symptom: Return electrode / pad fault
- Confirm the presentation - typically pad alarm, no activation - and note the exact alarm or message and the conditions when it occurs.
- Check the most likely cause first: poor contact or expired pad.
- Isolate the affected subsystem using the manufacturer's functional check or self-test, where one is provided.
- If the fault is confirmed and not a field adjustment, service or replace the return electrode (patient plate) per the manufacturer's service documentation.
- Return the device to service only after the manufacturer's functional and applicable electrical-safety checks pass.
- Record the findings, any parts used, and the verification results in the maintenance history.
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
No documents available for this device yet.
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
Flash may be protruding from the lumen of the catheter shaft. If this flash is present in the catheter, there is the potential of an embolization resulting from the flash detaching from the device during the procedure.
- RECALL
Missing holes: Catheters are missing the catheter's side holes.
- RECALL
Excess strands of resin may exist in the lumen near the hub of certain batches/lots of the Mach 1 Guide Catheters. If this excess resin is present in the catheter, there is the potential of an embolization resulting from the excess resin detaching from the device during the procedure.
- RECALL
Boston Scientific is voluntarily recalling one lot/batch of Katzen Infusion Wires because they have identified that the label on the carton may indicate a different length device than what is actually in the carton. The affected batch was manufactured using the Katzen Core Assembly of 146 cm, instead of a 177cm assembly.
- RECALL
One lot of product, Stainless Steel Greenfield Vena Cava Filter, may have the incorrect expiration date of 2008-07 and the correct date is 2008-06.
- RECALL
The PT2 J-tip labeled guide wires may be missing the pre-formed J-tip. As a result, guide wires may have a straight tip instead of a pre-formed J-tip.
- RECALL
Lack of assurance of sterility (pre-sterilization bioburden limits exceeded)
- RECALL
Boston Scientific discovered through an internal inspection process that the PTFE (polytetrafluoroethylene) coating is not consistently adhering to the transition area of the distal end of the guide wires which may cause PTFE to flake off.
- RECALL
Gaps were identified between polymer segments on the 7F Wiseguide Guide Catheter in which the PTFE was not properly laminated to the braid of the catheter. This delamination of the PTFE from the braid could compromise the device delivery.
- RECALL
There have been reports of detachment at the bond between the carrier capsule and the outer sheath of the Greenfield Vena Cava Filters with 12 Fr Femoral introducer Systems manufactured before Marcyh 10, 2004. If the capsule should detach during an implantation procedure, there is a risk of cardiac and pulmonary embolization.
- RECALL
The device has the potential for overheating its transformer and has the potential for fire hazard.
- RECALL
The device has the potential for overheating its transformer and has the potential for fire hazard.
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