BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 109677 · Received July 30, 1997

    Report

    Report Number
    1527736-1997-01847
    Event Type
    Malfunction
    Date Received
    July 30, 1997
    Date of Event
    July 1, 1997
    Report Date
    July 2, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER ON 7/1/97 WHILE PERFORMING A UNK PROCEDURE. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #974203. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW: VISUAL INSPECTIONS & RESULTS: CLIP IN JAWS, YES; DAMAGED JAWS, DAMAGED CUTTER, NA; DAMAGED JAWS, DAMAGED FEED BAR, DAMAGED FLOOR, DAMAGED HANDLE SHROUDS, DAMAGED OTHER, DAMAGED TIP SHROUDS, DAMAGED TRIGGER, DAMAGED TUBE, AND DAMAGED WELD SEAMS, NO. FUNCTIONAL TESTS & RESULTS: ANTIBACKUP FUNCTIONAL, FIRING: FEED CONFORM, FIRING: FORM CONFORM, JAWS: HOLD CLIP, AND LOCKOUT FUNCTIONAL, YES; JAWS: INSIDE WIDTH AT TIPS, .186; AND NUMBER OF CLIPS FED AND FORMED, 8. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTINGS, NO CONCLUSION COULD BE REACHED AS TO WHAT HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT CYCLED, FED AND FORMED THE REMAINING CLIPS AS DESIGNED. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. 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

    IT WAS REPORTED THE DEVICE WAS USED DURING AN UNK PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE CLIPS WERE MALFORMED (GAP). 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 K45V05

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other