BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 102693 · Received July 2, 1997

    Report

    Report Number
    1527736-1997-01479
    Event Type
    Malfunction
    Date Received
    July 2, 1997
    Date of Event
    April 8, 1997
    Report Date
    July 1, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MISSING JAW (TOP AND LOWER) AND ALSO THE FEED SHOE. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #973464. VISUAL INSPECTIONS & RESULTS: CLIP IN JAW, A N/A BC NO; CONDITION OF HANDLE HALVES, ABC GOOD; CRIMP LOCATION, ABC GOOD; JAW CONDITION, A MISSING BC GOOD; JAW POSITION, A N/A BC OPEN; NUMBER OF CLIPS, A N/A BC 21 AND SHAFT CONDITION, ABC GOOD. FUNCTIONAL TESTS & RESULTS: ANTI-BACKUP FUNTIONAL, A N/A BC YES; COULD THE INSTRUMENT BE CYCLED, NO AND NUMBER OF CLIPS FIRED, A N/A BC 21. ANALYSIS CONCLUSION: BASED UPON INQUIRY INFO RECEIVED AND VISUAL EXAMINATION, IT WAS CONCLUDED THAT INSTRUMENT A WAS RETURNED ON 8/4/97 AND WAS MISSING JAWS, EMPTY, AND WAS MISSING FEED SHOE. NO TESTING COULD BE PERFORMED DUE TO CONDITION OF INSTRUMENT RETURNED. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. INSTRUMENTS B AND C WERE RETURNED ON 8/11/97, WERE IN UNOPENED, STERILE, PACKAGES AND WERE IN GOOD PHYSICAL CONDITION. STERILE INSTRUMENTS WERE CYCLED AND FED CLIPS AS DESIGNED. CLIP FORM WAS WITHIN DESIGN SPECIFICATION. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE CLIPS FEED PROPERLY AND THAT CLIP FOMR IS WITHIN DESIGN SPECIFICATION. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT WHEN THE DEVICE WAS BEING REMOVED, THE TIP OF THE DEVICE BROKE OFF. THE TIP WAS FOUND AND REMOVED. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ROTATING MULTIPLE CLIP APPLIER ENDOSCOPIC CLIP APPLIER GDO ETHICON ENDO-SURGERY, INC. NA J45E88

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other