BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 1924811 · Received December 14, 2010

    Report

    Report Number
    3005075853-2010-07082
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 18, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. HOWEVER, IT IS KNOWN FROM THE HISTORY OF THE DEVICE THAT THE INCORRECT/EXCESSIVE APPLICATION OF TORQUE TO THE JAWS DURING INSTRUMENT USE CREATES A MISALIGNMENT OF THE TIPS WHICH MAY RESULT IN CLIP MALFORMATION. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE WAS MISFIRING AND THE TIP OF CLIPS WERE CROSSING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP** ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4TZ27

    Patients

    Seq Age Sex Outcome Treatment
    1