BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR TRIPOLAR 90 SUCTION ELECT

    MDR report key: 17757268 · Received September 15, 2023

    Report

    Report Number
    1221934-2023-03452
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    August 31, 2023
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    GEI
    UDI-DI
    10886705023103
    PMA / PMN Number
    K143475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY ==>THE VAPR TRIPOLAR 90 SUCTION ELECT WAS RETURNED TO MANUFACTURER FOR EVALUATION. THE MANUFACTURER CONDUCTED VISUAL INSPECTION AND FUNCTIONAL TEST OF DEVICE RECEIVED BY CUSTOMER. VISUAL INSPECTION OF THE DEVICE WAS PERFORMED; AS A RESULT, THE RUBBER BOOT DISLODGED, AND NO SIGNS OF DAMAGE TO THE BOOT, THE HEAT SHRINK AT THE DISTAL END OF THE SHAFT WAS DAMAGED, THE SHAFT REMAINS STRAIGHT WITH NO SIGNS OF EXCESS FORCE BEING APPLIED. THE FUNCTIONAL AND ELECTRICAL TEST WERE PASSED WITHOUT PROBLEMS. THE DEVICE SHAFT REMAINED IN A GOOD CONDITION, BUT THE HEAT SHRINK WAS DAMAGED AT THE DISTAL END. THE RUBBER BOOT WAS REFITTED, AND THE RETENTION STRENGTH WAS CHECKED AND FOUND TO BE GREATER THAN THE MINIMUM RETENTION FORCE. BASED ON THE CONDITION OF THE RUBBER BOOT, THIS COMPLAINT CAN BE CONFIRMED. NO ISSUES (NCR OR DEVIATIONS) WITH THE MANUFACTURING PROCESS HAVE BEEN FOUND IN THE HRD REVIEW PERFORMED FOR THE COMPLAINT LOT U2305128 (JUN 2023) THAT MIGHT EXPLAIN ANY POSSIBLE OBSERVED FAILURES. IN ADDITION TO THIS THE RETENTION TEST OF THE RUBBER BOOT WAS CARRIED OUT SHOWING A STRENGTH OF 38.08 N BEING NECESSARY TO DISLODGE THE RUBBER BOOT. THIS VALUE IS FAR BIGGER THAT THE 16.25N CONSIDERED FOR THE DEVICE TO BE WITHIN SPECIFICATION, I.E., IF THE RUBBER BOOT DISLODGES USING LESS EFFORT THAT 16.25 THE DEVICE IS AT FAULT, IF THE RUBBER BOOT DISLODGES USING BIGGER EFFORT THE DEVICE IS CONSIDERED TO BE WORKING WITHIN SPECIFICATION. THE ELECTRODE IS WITHIN SPECIFICATION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, IN DEPUY SYNTHES MITEK, ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.

    Additional Manufacturer Narrative · 0

    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 DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: UDI: (B)(4). E3: REPORTER IS A J&J EMPLOYEE. H4: THE DEVICE MANUFACTURE DATE IS CURRENTLY UNAVAILABLE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 0

    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 DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: D9, H3, H6: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, A VAPR TRIPOLAR90 SUCTION ELECTRODE DEVICE WAS USED. ACCORDING TO THE REPORT, THE BLACK COVER ON THE SWITCH BUTTON CAME OFF THE DEVICE; AND THEREFORE, WAS NOT USED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294691 VAPR TRIPOLAR 90 SUCTION ELECT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI DEPUY MITEK LLC US U2305128 10886705023103

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown