BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 1844104 · Received September 24, 2010

    Report

    Report Number
    3005075853-2010-05493
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 31, 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
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CRIMP. THE ANALYSIS RESULTS OF THE (B)(4) FOUND THAT IT WAS RECEIVED WITH THE CRIMP NON-CONFORMING; THEREFORE, THE CLIPS COULD NOT BE PROPERLY FED INSIDE THE JAWS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE FOUND CONDITION. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. 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 WOULD NOT FIRE AND ANOTHER CLIPS WOULD NOT LOAD INTO THE JAWS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    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 F4PK49

    Patients

    Seq Age Sex Outcome Treatment
    1