BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR COOLPULSE 90 ELECTRODE, 90° SUCTION W/INTEGRATED HANDPIECE

    MDR report key: 9200541 · Received October 16, 2019

    Report

    Report Number
    1221934-2019-59052
    Event Type
    Malfunction
    Date Received
    October 16, 2019
    Date of Event
    September 18, 2019
    Report Date
    September 20, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    GEI
    UDI-DI
    10886705010080
    PMA / PMN Number
    K113545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. THE DEVICE WAS RECEIVED AND EVALUATED.THIS COMPLAINT CAN BE CONFIRMED. IT WAS OBSERVED THAT THE ACTIVE TIP OF THE DEVICE APPEARED ACTIVATED AND SALINE RESIDUE WAS PRESENT IN THE SUCTION TUBING INDICATING THAT THE DEVICE HAD BEEN PREVIOUSLY USED.UPON VISUAL INSPECTION IT WAS OBSERVED THAT THE METAL TIP WAS MISSING. THE DEVICE WAS FORWARDED TO THE MANUFACTURER FOR FURTHER INVESTIGATION INTO THE OBSERVED FAILURES.THE MANUFACTURER INDICATED THAT ELECTRICAL AND FUNCTIONAL TESTS CANNOT BE PERFORMED DUE TO DEVICE DAMAGE.THE COMPLAINT OF THE ACTIVE TIP DETACHING WAS CONFIRMED. THE DEVICE WAS RETURNED WITH THE ACTIVE TIP MISSING, THE TIP ITSELF HAD NOT BEEN RETURNED FOR EXAMINATION. IT APPEARS THAT THE SUCTION TUBE HAS ERODED AT THE JUNCTURE BETWEEN ITSELF AND THE ACTIVE TIP. SIMILAR INSTANCES OF THESE TYPES OF FAILURES HAVE BEEN OBSERVED HISTORICALLY. THE FAILURE MODE SEEN IS CONSISTENT WITH OTHER COMPLAINT DEVICES INVESTIGATED UNDER CAPA-101220 WHICH WAS OPENED TO INVESTIGATE THE OCCURRENCE OF ACTIVE TIP FAILURES IN THE FIELD. THE POTENTIAL ROOT CAUSE FOR THIS CAPA WAS IDENTIFIED AS: A) THE WELD BRIDGE ON ACTIVE SUCTION TUBE IS NOT PROVIDING SUFFICIENT WELD MATERIAL AND RETENTION. B) MECHANICAL FATIGUE DUE TO STRESS CORROSION PITTING / CORROSION AND DUE TO WELDING PROCESS. C) MISUSE, (E.G. EXTENDED ACTIVATION OR OVERLOADING OF MECHANICAL FORCES). A REVIEW OF OUR COMPLAINT RECORDS OVER THE LAST 12 MONTHS TO ASSESS THE FREQUENCY OF THIS DEFECT FOR THE 228146 DEVICE WHICH THE SHOWS THE FREQUENCY OF OCCURRENCE IS OF LOW AND AS ANTICIPATED IN THE RISK ANALYSIS BASED ON THREE CONFIRMED FAILURES IN 49,760 SALES. THE PREVIOUS CONFIRMED FAILURES IN THE 12 MONTHS WERE COMPLAINTS (B)(4) RECEIVED IN OCTOBER & NOVEMBER 2019. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER U1810009, AND NO NON-CONFORMANCES WERE IDENTIFIED. AT THIS POINT, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. DEVICE HISTORY A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER (B)(4), AND NO NON-CONFORMANCES WERE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRO-CODE: HRX. COMPLAINANT PART HAS BEEN RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED. 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. UDI: (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES MITEK REPORTS AN EVENT IN (B)(6) AS FOLLOWS: COMPONENT DAMAGED. IT WAS REPORTED THAT DURING THE LACERATION OF SUPRASPINATUS MUSCLE OF SHOULDER JOINT SURGERY, THE BLACK COMPONENT DETACHED FROM THE DEVICE AND FELL OFF AS THE PHOTOS SHOW, REMOVED IT FROM THE PATIENT, ALL THE PIECES WOULD BE RETURNED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS COMPLAINT IS FOR ONE (1) VAPR COOLPULSE 90 ELECTRODE, 90° SUCTION W/INTEGRATED HANDPIECE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992772 VAPR COOLPULSE 90 ELECTRODE, 90° SUCTION W/INTEGRATED HANDPIECE ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE GEI DEPUY MITEK LLC US 228146 U1810009 10886705010080

    Patients

    Seq Age Sex Outcome Treatment
    1