BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE GSI SPACESEAL EPS 10/11MM

    MDR report key: 322052 · Received March 19, 2001

    Report

    Report Number
    1219161-2001-00060
    Event Type
    Malfunction
    Date Received
    March 19, 2001
    Report Date
    March 19, 2001
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, A GSI SPACESEAL DEVICE WAS PLACED IN THE SURGEON'S HERNIA KIT INSTEAD OF A GSI SPACEMAKER - PRODUCT CODE 174016. UPON USING THE INCORRECT PRODUCT, THE PT'S PERITONEUM WAS PERFORATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12125 AUTO SUTURE GSI SPACESEAL EPS 10/11MM DISPOSABLE ENDOSCOPIC TROCAR GCJ UNITED STATES SURGICAL CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN