BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GDO LIGACLIP MCA LARGE APPLIER

    MDR report key: 1469452 · Received June 12, 2009

    Report

    Report Number
    3005075853-2009-03492
    Event Type
    Malfunction
    Date Received
    June 12, 2009
    Date of Event
    March 31, 2009
    Report Date
    May 26, 2009
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). EVAL SUMMARY: NO CONCLUSION COULD BE REACHED BASED ON THE ANALYSIS RESULTS AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FED, AND FORMED THE CLIPS PROPERLY. IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING TO MANUFACTURING SPECIFICATIONS. WHILE WE WERE UNABLE TO RE-CREATE THE EVENT, 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 DURING AN OPEN CHOLECYSTECTOMY PROCEDURE, THE CLIPS WERE TWISTING. A NEW DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDO LIGACLIP MCA LARGE APPLIER GDO ETHICON ENDO-SURGERY, LLC NA E4M69L

    Patients

    Seq Age Sex Outcome Treatment
    1