BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE ENDO GIA II 60-3.5 SULU

    MDR report key: 328972 · Received April 23, 2001

    Report

    Report Number
    1219930-2001-00212
    Event Type
    Malfunction
    Date Received
    April 23, 2001
    Date of Event
    March 26, 2001
    Report Date
    March 27, 2001
    Manufacturer
    UNITED STATES SURGICA CORP.
    Product Code
    GCJ
    Removal / Correction Number
    UNK
    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 LAPAROSCOPIC COLON PROCEDURE. REPORTEDLY, THE KNIFE TRANSECTED AND THE STAPLES DID NOT FORM. ANOTHER DEVICE WAS USED TO FINISH THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18454 AUTO SUTURE ENDO GIA II 60-3.5 SULU ENDOSCOPIC STAPLER GCJ UNITED STATES SURGICA CORP. NA N1A96

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN