BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 85042 · Received April 15, 1997

    Report

    Report Number
    1628808-1997-00139
    Event Type
    Malfunction
    Date Received
    April 15, 1997
    Date of Event
    October 4, 1996
    Report Date
    April 8, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE FIRST ER320 SPIT CLIPS OUT OF THE JAWS. THE SECOND ER320 WORKED FINE UNTIL THE SURGEON PLACED A CLIP AROUND A METAL CATHETER TO HOLD IT IN PLACE IN THE DUCT. THE CLIP FORMED ON THE CATHETER, BUT THE NEXT CLIP WOULD NOT SEAT IN THE JAWS PROPERLY. A THIRD ER320 WAS OPENED TO COMPLETE THE CASE. ONLY THE SECOND INSTRUMENT IS BEING RETURNED. THERE WAS NO CONSEQUENCE TO THE PT. 1/24/97 1115 SURGEON NOT AVAILABLE. RECEPTIONIST STATED SURGEON SPOKE TO EES FEW DAYS AGO AND DOESN'T REMEMBER ANYTHING ABOUT THE REPORTED EVENT SINCE IT WAS 3 MONTHS AGO.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other