BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1081893 · Received July 22, 2008

    Report

    Report Number
    3005075853-2008-00617
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    May 29, 2008
    Report Date
    June 11, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT 07/22/2008. SHAFT, CAM. EVAL SUMMARY: THE ANALYSIS RESULTS FOUND THAT ONE EL5ML DEVICE WAS REC'D WITH THE SHAFT DAMAGED AND THE JAWS DISENGAGED FROM THE CAM. THE DEVICE WAS TESTED FOR FUNCTIONALITY AND IT EJECTED THE REMAINING CLIPS DUE TO THE CONDITION OF THE JAWS. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE SHAFT BECAME DAMAGED. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MFG TO ENSURE THE DEVICE MEETS THE REQUIRE SPECS PRIOR TO SHIPMENT, IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT FGQA. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE DEVICE WAS FIRED A "POP" SOUND WAS HEARD. THE END OF THE DEVICE WAS SPLIT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER FZP ETHICON ENDO-SURGERY, LLC NA E4KR6E

    Patients

    Seq Age Sex Outcome Treatment
    1