BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE ENDO CATCH 10MM

    MDR report key: 172405 · Received June 11, 1998

    Report

    Report Number
    2647580-1998-00750
    Event Type
    Malfunction
    Date Received
    June 11, 1998
    Date of Event
    May 7, 1998
    Report Date
    May 14, 1998
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    1/25/1999- SUPPLEMENTAL REPORT SENT TO FDA.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A LAPAROSCOPY PROCEDURE. REPORTEDLY, THE INSTRUMENT BROKE AND A COMPONENT DISENGAGED INTO THE PT'S CAVITY. THE SURGEON WAS ABLE TO REMOVE THE COMPONENT AND COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE ENDO CATCH 10MM SPECIMEN RETRIEVAL POUCH GCJ UNITED STATES SURGICAL CORP. NA P8B174

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN