BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVIDIEN

    MDR report key: 6922121 · Received October 6, 2017

    Report

    Report Number
    MW5072635
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    September 15, 2017
    Report Date
    October 4, 2017
    Manufacturer
    COVIDIEN
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC TOTAL COLECTOMY, COVIDIEN CIRCULAR STAPLER WAS FIRED AND REMOVAL OF THE STAPLER WAS DIFFICULT AS SOME RESISTANCE WAS MET. THE STAPLE WAS EVENTUALLY WITHDRAWN, HOWEVER, THE ANVIL WAS RETAINED IN THE LUMEN. IN ADDITION, SOME BLEEDING OCCURRED IN THE MESENTERY AND WAS CONTROLLED BY CLIPS. TO REMOVE THE ANVIL, THE FLEXIBLE SIGMOIDOSCOPE WAS INTRODUCED AND AN ENDOSCOPIC NET WAS USED WITHOUT SUCCESS. AN ENDO LOOP WAS INTRODUCED INTO THE RECTUM WITHOUT SUCCESS AS WELL. FINALLY, USING A BIOPSY FORCEPS, THE DONUT WAS GRASPED AND THE ANVIL REMOVED GUIDED BY LAPAROSCOPY. PATIENT WAS TAKEN BACK TO SURGERY THREE DAYS LATER WITH ANASTOMOTIC LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705201 COVIDIEN COVIDIEN STAPLER WITH DTS SERIES GAG COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization