BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN

    MDR report key: 1635191 · Received March 15, 2010

    Report

    Report Number
    MW5015173
    Event Type
    Malfunction
    Date Received
    March 15, 2010
    Date of Event
    March 9, 2010
    Report Date
    March 15, 2010
    Manufacturer
    VALLEY LAB/DIVISION OF TYCO HEALTHCARE GROUP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LIGASURE DEVICE NOT SEALING CORRECTLY THEREBY CAUSING BACK BLEEDING. DEVICE DID NOT STOP BLEEDING AND HAD TO USE BIPOLAR DEVICE AND CORD TO COMPLETE CASE. DATES OF USE: (B) (6). DIAGNOSIS OR REASON FOR USE: LAP ASSISTED HYSTERECTOMY, VAGINAL BSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COVIDIEN LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER 5MM GEI VALLEY LAB/DIVISION OF TYCO HEALTHCARE GROUP 179496

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other