BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVIDIEN

    MDR report key: 7013871 · Received November 9, 2017

    Report

    Report Number
    MW5073228
    Event Type
    Injury
    Date Received
    November 9, 2017
    Date of Event
    January 4, 2017
    Report Date
    November 6, 2017
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PRODUCT - EEA AUTOSUTURE DID NOT FIRE AS IT IS INTENDED TO DO, MISFIRE CAUSED TEAR IN BOWEL. PT WAS UNDERGOING HAND ASSISTED LAPAROSCOPIC SIGMOID COLON RESECTION WITH STAPLED TO END TO END ANASTOMOSIS. AFTER REPAIR WAS COMPLETED, THERE WAS NO EVIDENCE OF LEAK, BLEEDING OR PERFORATION. PT RECOVERED WITH NO KNOWN FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795146 COVIDIEN EEA AUTOSUTURE CIRCULAR STAPLER W/ DST SERIES GDW COVIDIEN REF EEA28 P5F0103KX

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R