BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 2990237 · Received March 5, 2013

    Report

    Report Number
    3005075853-2013-01046
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 25, 2013
    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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: THE DEVICE WAS RETURNED FOR ANALYSIS 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. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. PHOTOGRAPHIC ANALYSIS: THE TEAR DROP/PEAR SHAPE CLIP FORMATION WAS THE RESULT OF EXCESSIVE DOWNWARD FORCE PUSHING THE CLIP BACK INTO THE JAWS DURING FIRING. THE ISSUE AROUND ONE CLIP LEG LIFTING OUT OF THE CLIP TRACK AND NOT THE OTHER DURING FIRING IS NORMAL AND WHAT I WOULD EXPECT TO SEE IF ONE CLIP LEG IS RESTRICTED SLIGHTLY AT THE VERY BEGINNING OF THE FIRING STROKE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, SURGEON COMPLAINED THAT THE CLIPS FROM THE DEVICE WERE NOT APPROXIMATING WHEN FIRED UPON THE CYSTIC DUCT. THE SURGEON ALSO TOOK PICTURES OF THE PROXIMAL END OF THE CLIP LIFTING FROM ONE SIDE OF THE JAWS WHEN BEGINNING THE FIRING PROCESS. THE CASE WAS COMPLETED USING AN EL5ML CLIP APPLIER AND THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92963 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4C293

    Patients

    Seq Age Sex Outcome Treatment
    1