BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 95076 · Received May 29, 1997

    Report

    Report Number
    1527736-1997-01073
    Event Type
    Malfunction
    Date Received
    May 29, 1997
    Date of Event
    April 25, 1997
    Report Date
    May 29, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH YOUR LIGACLIP MULTIPLE CLIP APPLIER WHILE PERFORMING A LAP CHOLECYSTECTOMY. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #972697. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: CLIP IN JAWS NO, DAMAGED JAWS NO, DAMAGED CUTTER N/A, DAMAGED FEED BAR NO, DAMAGED FLOOR NO, DAMAGE HANDLE SHROUDS NO, DAMAGED OTHER NO, DAMAGED TIP SHROUDS NO, DAMAGED TRIGGER NO, DAMAGED TUBE NO, DAMAGE WELD SEAMS NO. FUNCTIONAL TESTS & RESULTS: ANTIBACKUP FUNCTIONAL YES, FIRING: FEED CONFORM YES, FIRING: FORM CONFORM YES, JAWS: HOLD CLIP YES, JAWS: INSIDE WIDTH AT TIPS .172, LOCKOUT FUNCTIONAL YES, NUMBER OF CLIPS FED AND FORMED 16. ANALYSIS CONCLUSION: BASED ON THE INFO RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSON COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. UPON RECEIPT, THE INSTRUMENT WAS EXAMINED FOR ANY MISSING PLASTIC PARTS OF THE INSTRUMENT. THE ENTIRE INSTRUMENT WAS INTACT. THERFORE, IT COULD NOT BE DETERMINED AS TO HOW OR WHY SOME PLASTIC REPORTEDLY FELL OFF THE INSTRUMENT. THE INSTRUMENT FED, FIRED AND FORMED THE REMAINING CLIPS AS DESIGNED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYSTECTOMY "SOME PLASTIC FELL OFF THE TIP OF THE CLIP APPLIER AND NEEDED TO BE RETRIEVED FROM THE PT". THE ER320 CLIP APPLIER WAS USED. A NEW APPLIER WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT. 5/5/97 REP RESPONDED THE PLASTIC FELL OFF OF THE TIP OF THE CLIP APPLIER.

    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 K46375

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other