BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYCO HEALTHCARE AUTOSUTURE

    MDR report key: 1152246 · Received August 13, 2008

    Report

    Report Number
    1152246
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 13, 2008
    Manufacturer
    UNITED STATES SURGICAL CORP. (COVIDIEN)
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WENT TO THE OR FOR A LOW ANTERIOR RESECTION OF THE RECTOSIGMOID COLON SECONDARY TO CANCER. THE DISTAL PART OF THE EEA STAPLER WAS PUT IN PLACE TO THE PROXIMAL BOWEL AND THE PURSESTRING SUTURE WAS TIED OVER. THE RECTUM WAS DILATED USING FIRST THREE DILATORS, THEN EEA STAPLER WAS ADVANCED WHEN WE NOTICED THAT THERE WERE NO STAPLES IN THE RECTUM. APPARENTLY, THE STAPLER WE USED DID NOT FIRE. NO STAPLES ON BOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYCO HEALTHCARE AUTOSUTURE STAPLER, SURGICAL GDW UNITED STATES SURGICAL CORP. (COVIDIEN) TA 60 3.5MM P8D0362

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR NO OTHER THERAPIES| NO OTHER THERAPIES