BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVIDIEN

    MDR report key: 2467272 · Received February 20, 2012

    Report

    Report Number
    MW5024330
    Event Type
    Injury
    Date Received
    February 20, 2012
    Date of Event
    December 27, 2011
    Report Date
    February 20, 2012
    Manufacturer
    COVIDIEN - VALLEY LAB
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS PERFORMING EXAM UNDER ANESTHESIA. EXPLORATORY LAPAROTOMY. LYSIS OF ADHESION. TOTAL ABDOMINAL HYSTERECTOMY. BILATERAL SALPINGO-OOPHORECTOMY. EN BLOC RECTOSIGMOID RESECTION. UPPER VAGINECTOMY. BILATERAL PELVIC PERIAORTIC LYMPH NODE DISSECTION. OMENTECTOMY. APPENDECTOMY. CYSTOSCOPY. MOBILIZATION OF SPLENIC FLEXURE. A 25-MM SIDE END, FUNCTIONAL END-TO-END RECTOSIGMOID ANASTOMOSIS. THIS WAS THE SECOND OF TWO COVIDIEN LIGASURE IMPACT TISSUE FUSION OPEN INSTRUMENTS THAT MALFUNCTIONED BY THE JAWS NOT REOPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COVIDIEN COVIDIEN LIGASURE IMPACT TISSUE FUSION OPEN GEI COVIDIEN - VALLEY LAB LF4200 218445LX

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Disability