BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 3022620 · Received March 13, 2013

    Report

    Report Number
    3022620
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 13, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CONTOUR STAPLE DEVICE DID NOT FIRE ANY STAPLES. THIS WAS DISCOVERED BY THE SURGEON DURING HIS LOW ANTERIOR ASSESSMENT. HE HAD TO USE A SUTURE TO SEW THE AREA REQUIRING STAPLES. NO STAPLES WERE SEEN IN PATIENT NOR IN DEVICE PER SURGICAL TECH.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?1. EXPLORATORY LAPAROTOMY AND LYSIS OF DENSE ADHESIONS FROM PREVIOUS SURGERY.2. SIGMOID RE-COLECTOMY AND LOW PELVIC ANASTOMOSIS BETWEEN (EEA 25 MM STAPLER).3. POSTERIOR RECTOPEXY WITHOUT USE OF MESH.4. TEMPORARY DIVERTING TRANSVERSE COLON LOOP COLOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106788 CONTOUR STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR