Ethicon Ultracision Harmonic Scalpel
Ethicon · Model Ultracision Harmonic Scalpel
• Fast and easy setup and operation • On-screen diagnostics • Viewable from wide range of angles Universal Connector • Teardrop shape ensures proper alignment and limits potential damage to hand piece and device connector • Magnetized for ease of use and to ensure proper seating of connector • Automatic instrument recognition Compact Design • Takes up less space in the OR • Multiple placement options in the OR (cart, stand, or boom) • Allows for easy transportation between ORs Upgradeable Software • Designed to promote compatibility with future energy devices • Allows for future expansion to other products to limit the obsolescence of capital One generator for all HARMONIC® and ENSEAL® Devices • Powers current and future Ethicon Energy devices
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.
Electrosurgical electrode wear
MediumSymptoms: Poor cut/coag, sparking, low power.
Root cause: Burned/eroded blade or pencil.
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.
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.
Foot switch assembly
Class Periodic replacementRel. cost $$R&R Fairly easy
OR light LED module
Class Major service partRel. cost $$$R&R Difficult
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
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Foot switch assembly | Periodic replacement | $$ | Fairly easy |
| OR light LED module | Major service part | $$$ | Difficult |
| Table hydraulic actuator | Periodic replacement | $$$ | Difficult |
| Instrument repair / replacement set High-turnover consumable instruments. | Periodic replacement | $$ | Fairly 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.
Technical Specs
- OutPut Frequency
- 55 kHz
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
An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns
- RECALL
The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.
- RECALL
Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging.
- RECALL
Ethicon Endo-Surgery initiated a voluntary recall due to some lot numbers of the HARMONIC Hand Piece (HP054) and the HARMONIC Blue Hand Piece (HPBLUE), which impacts their compatibility with the HARMONIC Generator 300 (GEN04). The problem occurs after successful set up and initial use of HARMONIC Hand Pieces (HP054 and HPBLUE) with the Generator 300 (GEN04). The procedure is interrupted when
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