VAPR S90 4.0MM W/INTEGR HDP -EA
Report
- Report Number
- 1221934-2025-01199
- Event Type
- Malfunction
- Date Received
- April 2, 2025
- Date of Event
- March 27, 2025
- Report Date
- April 2, 2025
- Manufacturer
- DEPUY MITEK LLC US
- Product Code
- GEI
- UDI-DI
- 10886705009398
- PMA / PMN Number
- K082643
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. H11: ADDITIONAL NARRATIVE: D9, H3, H6: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, AND IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.
THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION SUMMARY: THE PRODUCT HAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS, HOWEVER A PHOTO WAS PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PHOTO FOUND NO OBSERVATIONS PERTAINING TO THE NATURE OF THE REPORTED EVENT OR ANY OTHER ANOMALY. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE VAPR S90 4.0MM W/INTEGR HDP -EA WOULD HAVE NOT CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE FINDINGS, THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS AND NO POTENTIAL CAUSE ABOUT THE REPORTED EVENT CAN BE ESTABLISHED DUE TO THE INSUFFICIENT EVIDENCE PROVIDED. IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES.
THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION SUMMARY THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT DEVICE WAS NOT RECEIVED IN ITS ORIGINAL PACKAGING, THE TIP SHOWED SIGNS OF ACTIVATION. THE HANDLE, SHAFT AND PLUG DID NOT SHOW ANY SIGNS OF DAMAGE. THE DEVICE WAS CONNECTED TO THE TEST GENERATOR, AS A RESULT, IT WAS FOUND THAT IN THE COAGULATE MODE THE DEVICE WORKED AS INTENDED USING THE FOOTPEDAL, THE ABLATE FUNCTION WAS FUNCTIONING INTERMITTENTLY WHEN USING THE FOOTPEDAL. THE ELECTRODE WILL BE SENT TO THE MANUFACTURER FOR FURTHER EVALUATION. A VISUAL INSPECTION OF THE DEVICE WAS PERFORMED; AS A RESULT, DEVICE WAS RECEIVED ONLY IN THE SHELF CARTON BOX, THE TIP WAS IN USED CONDITION WITH CRYSTALIZED SALINE RESIDUE, PROCEDURAL RESIDUE WAS VISIBLE IN SUCTION TUBE. THE DEVICE PASSED THE FUNCTIONAL AND ELECTRICAL TESTING. THE DEVICE FUNCTIONED AS INTENDED, NO ISSUES WERE OBSERVED. THE CUSTOMER STATED THAT DURING THE OPERATION, THE DEVICE SUDDENLY FAILED TO WORK AND WAS UNABLE TO ABLATE AND STOP BLEEDING'. THE COMPLAINT DEVICE HAS BEEN RETURNED TO ATL UK FOR INVESTIGATION. THE DEVICE WAS INVESTIGATED AND PASSED ALL ELECTRICAL AND FUNCTIONAL TESTS. THE ELECTRODE FUNCTIONED AS INTENDED, NO ISSUES WERE OBSERVED. THIS COMPLAINT CANNOT BE SUBSTANTIATED. IT HAS BEEN ACKNOWLEDGED THAT THE MITEK JUAREZ LABORATORY REPORTED THE ABLATE FUNCTION INTERMITTENTLY WHEN USING THE FOOTPEDAL, HOWEVER THIS INTERMITTENT FUNCTION COULD NOT BE REPRODUCED AT ATL UK. NO FAULTS WERE FOUND. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE VAPR S90 4.0MM W/INTEGR HDP -EA WOULD HAVE NOT CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE FOR THE REPORTED CONDITION CANNOT BE ESTABLISHED. IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY RECORD REVIEW: A DEVICE HISTORY REVIEW WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED RELATED TO THE REPORTED CONDITION.
THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. H11: ADDITIONAL NARRATIVE: CORRECTION: H4: THE DEVICE MANUFACTURE DATE HAS BEEN CORRECTED.
THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. H11: ADDITIONAL NARRATIVE: E1: THE REPORTER¿S COMPLETE FACILITY NAME WAS NOT PROVIDED AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED.
THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE VAPR S90 4.0MM W/INTEGR HDP -EA DEVICE SUDDENLY FAILED TO WORK, LEADING TO A FAILURE IN ENERGY EXCITATION, WHICH MADE IT IMPOSSIBLE TO ABLATE AND STOP BLEEDING. RESTARTING THE DEVICE DID NOT RECTIFY THE ISSUE, AND ENERGY OUTPUT COULD NOT BE ACHIEVED. TWO REPLACEMENT DEVICES WERE USED TO CONTINUE THE SURGERY, BUT THE SAME ISSUE OCCURRED AGAIN. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 745651 | VAPR S90 4.0MM W/INTEGR HDP -EA | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | DEPUY MITEK LLC US | U2405064 | 10886705009398 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |