BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 87369 · Received April 24, 1997

    Report

    Report Number
    1527736-1997-00774
    Event Type
    Malfunction
    Date Received
    April 24, 1997
    Date of Event
    March 26, 1997
    Report Date
    April 24, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 400: YIELDED JAWS. FACILITY EXPERIENCED AN EVENT WITH YOUR LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER WHILE PERFORMING A WEDGE RESECTION. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO US WITH PRODUCT INQUIRY #972119. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: CLIP IN JAW NO, DAMAGED JAWS YES, DAMAGED CUTTER N/A, DAMAGED FEED BAR N/A, DAMAGED FLOOR NO, DAMAGED HANDLE SHROUDS NO, DAMAGED OTHER NO, DAMAGED TIP SHROUDS NO, DAMAGED TRIGGER NO, DAMAGED TUBE NO, DAMAGED WELD SEAMS NO. FUNCTIONAL TESTS & RESULTS: ANTIBACKUP FUNCTIONAL YES, FIRING: FEED CONFORM YES, FIRING: FORMCONFORM NO, JAWS: HOLD CLIP YES, JAWS: INSIDE WIDTH AT TIPS .202, LOCKOUT FUNCTIONAL YES. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, IT WAS CONCLUDED THAT THE JAWS HAD BECMOME DAMAGED AND WOULD NOT FORM THE CLIPS PROPERLY. NO CONCLUSION COULD BE REACHED AS TO HOW THE DAMAGE TO THE JAWS OCCURRED. IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT FORM THE CLIPS PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY. CO STRIVES TO UNDERSTAND ECAH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A WEDGE RESECTION (VATS). IT WAS REPORTED BY THE AFFILIATE THAT WHEN THE SURGEON FIRED THE DEVICE, HE FOUND THAT THE CLIPS WERE NOT FORMING. IT WAS NOTED THAT ALL THE CLIPS HAD THE SAME PROBLEM. THERE WAS NO PT CONSEQUENCE.

    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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other