BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 57594 · Received October 4, 1996

    Report

    Report Number
    1527736-1996-00242
    Event Type
    Malfunction
    Date Received
    October 4, 1996
    Date of Event
    September 4, 1996
    Report Date
    October 4, 1996
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    9/9/96 1410 MESSAGE AND 800# LEFT FOR MD CALL BACK. 9/11/95 0940 NNCL SENT. A1,2,3,4,B6,7,D10-INFO NOT PROVIDED BY USER FACILITY. H4,D5-INFO NOT AVAILABLE. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED AND FED THE CLIPS AS DESIGNED. THE CLIP FORM WAS WITHIN DESIGN SPECIFICATION. IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. IF THE JAWS ARE NOT PLACED OVER THE ENTIRE VESSEL AND FIRED, THE CLIP WILL SLIDE OFF THE VESSEL. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED PROPERLY AND THAT THE CLIP FORM IS WITHIN DESIGN SPECIFICATION.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE CYSTIC DUCT WAS VERY LARGE. THE FIRST CLIP WAS PLACED ON THE DUCT, AND UPON ATTEMPTING TO PLACE A SECOND CLIP, THE FIRST CLIP HAD SLIPPED PARTIALLY OFF THE DUCT. SUBSEQUENT FIRINGS ALSO LOCKED IN THE JAWS OF THE DEVICE. SOME CLIPS EJECTED FROM THE JAWS. THE CASE WAS COMPLETED BY CONVERTING THE SUBXYPHOID PORT TO 11MM AND USING ANOTHER DEVICE PLACED CLIPS.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other