BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE ENDO CLIP 5MM

    MDR report key: 183433 · Received August 19, 1998

    Report

    Report Number
    1219161-1998-01354
    Event Type
    Malfunction
    Date Received
    August 19, 1998
    Date of Event
    May 12, 1998
    Report Date
    July 23, 1998
    Manufacturer
    UNITED STATES SURGICAL CORP
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NOT ADVANCE PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORT NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE ENDO CLIP 5MM DISPOSABLE CLIP APPLIER GCJ UNITED STATES SURGICAL CORP NA U8B95

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN