BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN - MEDTRONIC, CURICULAR STAPLER

    MDR report key: 6442381 · Received March 24, 2017

    Report

    Report Number
    MW5068724
    Event Type
    Malfunction
    Date Received
    March 24, 2017
    Date of Event
    February 8, 2017
    Report Date
    March 24, 2017
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A SIGMOID BOWEL RESECTION, THE TWO EDNS OF BOWEL WERE RE-ANASTOMOSED USING A CIRCULAR STAPLER. AFTER STAPLER WITHDRAWAL IT WAS DISCOVERED THAT THE DISTAL PORTION, THE ANVIL, WAS MISSING FROM THE STAPLER. UPON RE-INSPECTION OF THE ANUS, THE DISTAL PORTION WAS FOUND WITH AN INTACT "DONUT." THE COVIDIEN REP WAS CALLED TO THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214270 COVIDIEN - MEDTRONIC, CURICULAR STAPLER COVIDIEN CURICULAR STAPLER GAG

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR