BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 39548 · Received August 30, 1996

    Report

    Report Number
    1527736-1996-00072
    Event Type
    Malfunction
    Date Received
    August 30, 1996
    Date of Event
    August 7, 1996
    Report Date
    August 29, 1996
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 400: YIELDED JAWS. VISUAL INSPECTIONS & RESULTS: CLIP IN JAWS; A NO B YES. DAMAGED JAWS; A YES B NO. DAMAGED FEED BAR, DAMAGED HANDLE SHROUDS, DAMAGED TIP SHROUDS, DAMAGED TRIGGER, DAMAGED TUBE, AND DAMAGED WELD SEAMS; AB NO. FUNCTIONAL TESTS & RESULTS: ANTIBACKUP FUNCTIONAL; AB YES. FIRING: FEED CONFORM; A NO B YES. FIRING: FORM CONFORM; A NA B YES. JAWS: HOLD CLIP; A NO B YES. JAWS: INSIDE WIDTH AT TIPS; A .224 B .176. LOCKOUT FUNCTIONAL; AB YES. NUMBER OF CLIPS FED AND FORMED; A 6 EJECTED. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS OF INSTRUMENT A HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. INSTRUMENT B WAS RETURNED WITH NO PRELOAD OF THE JAW AGAINST THE TOP SHROUD. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. THE INSTRUMENT WAS CYCLED, FED, AND FORMED THE CLIPS WITHIN DESIGN SPECIFICATION. A) IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. B) A MODIFIED TOP SHROUD FROM REVISED TOOLING AND A LOWER SHROUD FROM A NEW TOOL WERE IMPLEMENTED TO MAINTAIN JAW PRELOAD AGAINST THE TOP SHROUD. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. THE DEVICE WAS SPITTING CLIPS. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER ENDOSCOPIC CLIP APPLIER GDO ETHICON ENDO-SURGERY, INC. NA J42F83

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other