BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR TRIPOLAR 90 SUCTION ELECT

    MDR report key: 8448857 · Received March 25, 2019

    Report

    Report Number
    1221934-2019-56675
    Event Type
    Malfunction
    Date Received
    March 25, 2019
    Date of Event
    February 25, 2019
    Report Date
    April 18, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    GEI
    UDI-DI
    10886705023103
    PMA / PMN Number
    K143475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4).

    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. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4). 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 ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    (B)(4). 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY ==> THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. THE SUCTION TUBE APPEARS TO HAVE BEEN USED, WITH SIGNS OF DRIED SALINE EVIDENT. THE DEVICE WAS SENT TO THE SUPPLIER FOR FURTHER EVALUATION AND TESTING. TEST RESULTS OF THE DEVICE CAN BE FOUND IN THE INVESTIGATION REPORT ATTACHED. THE SUPPLIER REPORTED THE FOLLOWING: THE REPORTED SUCTION FAILURE WAS NOT CONFIRMED. HENCE, THIS COMPLAINT CANNOT BE CONFIRMED. HOWEVER, ANOTHER DEFICIENCY WAS FOUND TO BE IMPAIRING THE DEVICE FUNCTION. VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED EVIDENCE OF DAMAGE AT THE DISTAL END OF THE DEVICE CAUSED BY AN ELECTRICAL SHORT. WHEN PERFORMING THE HIPOT TEST A FAIL WAS RECORDED AND THE POINT OF FAILURE WAS OBSERVED AT THE DAMAGED SECTION. THE ACTIVATION TESTS RESULTED IN AN ¿OUTPUT SHORTED¿ MESSAGE APPEARING ON THE GENERATOR ON ABLATE MODE. THE CAUSE OF THE ISSUE IS MOSTLY LIKELY DUE TO A DIRECT PATH BEING CREATED BETWEEN THE ACTIVE AND RETURN CIRCUIT AT THE DISTAL END. THIS CAN BE CAUSED BY AN INCOMPLETE ADHESIVE SEAL, RESULTING IN AN INEFFECTIVE ISOLATION OF THE ACTIVE AND RETURN. ELECTRODES WHICH EXHIBIT A SIMILAR DEFECT HAVE BEEN FURTHER INVESTIGATED THROUGH SUPPLIER CAPA. FURTHERMORE, A DHR REVIEW HAS BEEN PERFORMED; NO ISSUES (NCRS OR DEVIATIONS) WITH THE MANUFACTURING PROCESS HAVE BEEN INDICATED WHICH MIGHT EXPLAIN THE FAILURES OBSERVED. THEREFORE NO CONTAINMENT OR CORRECTION ACTION RELATED TO THE INDIVIDUAL COMPLAINTS IS REQUIRED. DUE TO THE LOW FAILURE OCCURRENCE RATE, MINOR RISK TO END USER/PATIENT AND 100% LEAK INSPECTIONS ALREADY BEING CARRIED OUT ON THE MANUFACTURING LINE NO CORRECTIVE ACTION IS DEEMED NECESSARY AT THIS MOMENT IN TIME. COMPLAINT RATE WILL CONTINUE TO BE MONITORED. UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(6). UDI: (B)(4)-INCOMPLETE. THE EXPIRATION DATE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE VIA E-MAIL THAT THREE VAPR TRIPOLAR SUCTION ELECTRODES WERE BLOCKED ALMOST IMMEDIATELY, AND REQUIRED REPLACEMENT. NO OBVIOUS TECHNICAL ISSUES NOTED, AND FOR THE FOURTH WAND USED THERE WAS NO ISSUES AT ALL. THIS ISN'T THE FIRST TIME THIS SURGEON HAS REPORTED THESE ISSUES, SO HE REQUESTED TO TEST IF THERE IS AN ISSUE WITH THE BATCH. ALL THREE ISSUES OCCURRED DURING THE SAME CASE, A SUBACROMIAL DECOMPRESSION. 10 MINUTES DELAY IN THE SURGERY WAS REPORTED AND THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE LOT NUMBER IN USE WAS U1806091. THE AFFILIATE ALSO REPORTED THAT SUCTION WAS THROUGH AN INDEPENDENT SUCTION TUBE ATTACHED TO A NEPTUNE AND ALL THE SOFTWARE HAD BEEN UPGRADED RECENTLY (12), AND IT DEFINITELY WASN¿T RE PROCESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240041 VAPR TRIPOLAR 90 SUCTION ELECT ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE GEI DEPUY MITEK LLC US U1806091 10886705023103

    Patients

    Seq Age Sex Outcome Treatment
    1