BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE ENDO CATCH 10MM

    MDR report key: 117654 · Received September 2, 1997

    Report

    Report Number
    2647580-1997-01008
    Event Type
    Malfunction
    Date Received
    September 2, 1997
    Report Date
    August 4, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT BROKE AND A COMPONENT DISENGAGED INTO THE PT'S CAVITY. THE SURGEON WAS ABLE TO RETRIEVE THE COMPONENT WITH NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE ENDO CATCH 10MM DISPOSABLE ENDOSCOPIC INSTRUMENT GCJ UNITED STATES SURGICAL CORP. NA P7E245

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN