BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA 28 MM

    MDR report key: 6906770 · Received October 2, 2017

    Report

    Report Number
    MW5072554
    Event Type
    Injury
    Date Received
    October 2, 2017
    Date of Event
    September 1, 2017
    Report Date
    September 28, 2017
    Manufacturer
    COVIDIEN
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT LAPAROSCOPIC RESECTION OF COLON USING EEA STAPLER CEEA 28MM PREMIUM #111987. AFTER ANASTOMOSES WAS CONNECTED WITH TOP ANVIL DEVICE, SURGEON TURNED HANDLE TO LOCK AND PULLED STAPLER OUT THROUGH RECTUM. SURGEON DID NOT CHECK WHETHER DEVICE WAS INTACT. ONE DAY AFTER DISCHARGE, PATIENT HAD BOWEL MOVEMENT AND ANVIL WAS FOUND IN STOOL. CONCERN WITH DEVICE IS THAT ONCE SURGEON LOCKS DEVICE, THE ANVIL IS NOT SUPPOSED TO COME OFF THE STAPLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686399 PREMIUM PLUS CEEA 28 MM STAPLER, SURGICAL GAG COVIDIEN 111987

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization