BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR COOLPULSE90 ELECTRODE

    MDR report key: 11400352 · Received March 2, 2021

    Report

    Report Number
    1221934-2021-00730
    Event Type
    Malfunction
    Date Received
    March 2, 2021
    Date of Event
    December 2, 2020
    Report Date
    March 2, 2021
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    GEI
    UDI-DI
    10886705010080
    PMA / PMN Number
    K113545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: UDI: (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT THE SUCTION DID NOT WORK AT THE HANDPIECE WHILE THEY STARTED TO USE THE VAPR. THEY DID THEN CHANGE THE HANDPIECE TO A NEW ONE. THEY TRIED THREE PIECES, BUT NONE OF THEM WORKED. ALL WITH THE SAME LOT NUMBER. ALL THREE WERE THROWN IN THE GARBAGE, BUT THEY RETURNED TWO NEW ONES, THAT ARE STILL IN THE ORIGINAL BOX. ALSO, WITH THE SAME LOT NUMBER. THE TWO DEVICES HAVE BEEN RETURNED IN ITS ORIGINAL PACKAGING. THE PACKAGE IS SEALED AND UNOPENED. DUE TO THE FAILURE REPORTED IS RELATED TO SUCTION, THE DEVICES WERE SENT TO SUPPLIER FOR FURTHER EVALUATION. THE VAPR COOLPULSE90 ELECTRODE WAS EVALUATED BY THE SUPPLIER WITH THE FOLLOWING RESULTS: THE TWO DEVICES WERE RETURNED HAS PART OF THE COMPLAINT. THE DEVICE 1 EXHIBITED CONTAMINATION ON THE ACTIVE TIP AND RESIDUE IN THE SUCTION TUBE; AND THE DEVICE 2 EXHIBITED CONTAMINATION ON THE ACTIVE TIP. AS THE COMPLAINT WAS RELATED TO SUCTION AND THE DEVICES ARE UNUSED, ONLY FLOW TESTS ARE TO BE PERFORMED ON THE RETURNED DEVICES. THE CUSTOMER CLAIMED THAT THE SUCTION ON THREE DEVICES DID NOT FUNCTION. THESE DEVICES WERE NOT RETURNED SO PREVENTING INVESTIGATION OF THE ACTUAL COMPLAINT DEVICES. THE DEVICES WERE SUBJECTED TO FLOW TESTS AGAINST SPECIFICATION. ONE DEVICE SUCCESSFULLY PASSED THE TEST AND THE OTHER DEVICE WAS FOUND TO BE FULLY BLOCKED. THE BLOCKAGE IS MOST PROBABLY CAUSED BY UV GLUE ENTERING THE SUCTION PATH. THE COMPLAINT FAILURE MODE SEEN WITH DEVICE 2 HAS BEEN CAUSED BY UV GLUE WITHIN THE ACTIVE SUCTION TUBE AND CONSISTENT WITH OTHER COMPLAINT DEVICES INVESTIGATED UNDER CAPA NO. CAP-101588. THESE BLOCKAGES WERE IDENTIFIED AS UV GLUE MIGRATING TO THESE AREAS DUE TO THE UV GLUE NOT BEING CURED ENOUGH TO PREVENT MOVEMENT TO THE SUCTION PATH. THE CURING PROCESS WOULD THEN BE FULLY ACHIEVED WITH THE APPLICATION OF RADIATION AT THE STERILIZER. FURTHER INVESTIGATION INTO THIS FAILURE IS BEING CONDUCTED UNDER CAPA WITH PROCESS IMPROVEMENTS UNDER REVIEW. AS THIS FAILURE MODE IS STILL CURRENTLY UNDER INVESTIGATION THIS COMPLAINT WILL BE ADDED TO THE SCOPE OF THE CAPA. THE VISUAL INSPECTION ALSO HIGHLIGHTED CONTAMINATION ON THE ACTIVE TIP OF BOTH DEVICES, WHICH APPEARS TO BE FIBERS; FURTHER INVESTIGATION INTO THIS FAILURE IS BEING CONDUCTED UNDER (B)(4). A PRELIMINARY INVESTIGATION INTO THE FIBERS VISIBLE HAS CONCLUDED THAT THE MOST LIKELY CAUSE IS THE USE OF A DRY WIPE PROCESS DURING THE MANUFACTURE OF THE DEVICE WITHIN THE CLEAN ROOM. THE DRY WIPE (PART # 064012) IS BEING UTILIZED TO DRY AND WIPE AWAY EXCESS DEIONIZED WATER AFTER COMPLETION OF THE REQUIRED FUNCTIONAL TEST. THE USE OF THE WIPE IS NOT PRESCRIBED BY THE MANUFACTURING ASSEMBLY AIDS. A DHR REVIEW HAS BEEN PERFORMED FOR THE COMPLAINT DEVICE LOT NUMBER U2004090; NO ISSUES (NCRS OR DEVIATIONS) WITH THE MANUFACTURING PROCESS HAVE BEEN INDICATED WHICH MIGHT EXPLAIN THE FAILURES OBSERVED. AT THIS POINT IN TIME, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DISTRIBUTOR IN (B)(6) THAT THE VAPR COOLPULSE90 ELECTRODE DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE EXHIBITED CONTAMINATION ON ITS ACTIVE TIP AND RESIDUE IN THE SUCTION TUBE. IT WAS FURTHER DETERMINED THAT THE DEVICE WAS FULLY BLOCKED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296345 VAPR COOLPULSE90 ELECTRODE ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE GEI DEPUY MITEK LLC US 228146 U2004090 10886705010080

    Patients

    Seq Age Sex Outcome Treatment
    1