BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE ENDO GIA II 12MM STAPLER

    MDR report key: 317679 · Received February 21, 2001

    Report

    Report Number
    1219930-2001-00055
    Event Type
    Malfunction
    Date Received
    February 21, 2001
    Date of Event
    January 19, 2001
    Report Date
    January 26, 2001
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A THORACO BULLECTOMY. REPORTEDLY, AFTER FIRING, THE JAWS WOULD NOT OPEN. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6775 AUTO SUTURE ENDO GIA II 12MM STAPLER ENDOSCOPIC STAPLER GCJ UNITED STATES SURGICAL CORP. NA N0C484

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN