BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 255142 · Received December 15, 1999

    Report

    Report Number
    1527736-1999-06486
    Event Type
    Malfunction
    Date Received
    December 15, 1999
    Date of Event
    November 25, 1999
    Report Date
    November 28, 1999
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (1) ER DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED BY THE REP THAT THE FIRST TWO CLIPS FIRED PROPERLY. THE NEXT FOUR CLIPS SCISSORED AND TWO CLIPS CAME OUT SIMULTANEOUSLY FOR THE FINAL FIRING. THE SURGEON USED A SECOND ER320 WHICH FIRED WITHOUT INCIDENT TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER CLIP APPLIERS - ENDOSCOPIC GDO ETHICON ENDO-SURGERY, INC. NA M4FAOG

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other