BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** CLIP APPLIER

    MDR report key: 2070462 · Received April 27, 2011

    Report

    Report Number
    3005075853-2011-01744
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 7, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: WHICH FIRING DID THIS OCCUR ON? 4TH FIRING. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? NO. WAS THE CLIP FULLY ADVANCED INTO THE JAWS? UNKNOWN. DID THE PROCEDURE DRIVE THE NEED TO APPLY TORQUE OR TWISTING OF THE DEVICE? UNKNOWN. WHAT VESSEL WAS THE DEVICE FIRED ON? PLEASE SPECIFY THE SIZE OF THE VESSEL? UNKNOWN. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? UNKNOWN. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? INSIDE. THE DEVICE WAS RETURNED EMPTY AND UPON INSPECTION THE JAWS WERE FOUND TO BE IN A YIELDED CONDITION MAKING THE DEVICE NON-FUNCTIONAL. POSSIBLE CAUSES FOR THE CONDITION FOUND MAY BE IF THE DEVICE IS CLOSED OVER AN EXISTING HARD OBJECT OR CLIP PLACING STRESS ON THE JAWS CAUSING THEM TO DISTORT OR YIELD AND NOT RETURN TO THEIR ORIGINAL DIMENSIONS/POSITION OR EXCESSIVE APPLICATION OF TORQUE TO THE JAWS WHEN POSITIONING THE DEVICE ON A VESSEL. 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. IT IS KNOWN FROM THE HISTORY OF THE DEVICE THAT THE CONDITION OF THE JAWS MAY LEAD DROPPING/EJECTED CLIPS. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE THE FIRST THREE CLIPS WORKED PROPERLY AND THE FOURTH CLIP DROPPED OUT OF THE DEVICE UNFORMED. THEY COMPLETED THE PROCEDURE WITH A NEW LIKE DEVICE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1