BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE ROTIC ENDO GRASP 5MM

    MDR report key: 217004 · Received March 29, 1999

    Report

    Report Number
    2647580-1999-00285
    Event Type
    Malfunction
    Date Received
    March 29, 1999
    Date of Event
    February 1, 1999
    Report Date
    March 1, 1999
    Manufacturer
    UNITED STATES SURGICAL CORPORATION
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A GASTROPLASTY PROCEDURE. REPORTEDLY, THE INSTRUMENT BROKE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE ROTIC ENDO GRASP 5MM DISPOSABLE ENDOSCOPIC INSTRUMENT GCJ UNITED STATES SURGICAL CORPORATION NA P8J31

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN