BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL ROUND TIP

    MDR report key: 1931619 · Received December 13, 2010

    Report

    Report Number
    1931619
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 2, 2010
    Report Date
    December 13, 2010
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEONS IN THE CASE STATED THAT THE ENSEAL HANDPIECE WAS HARD TO CLOSE AND MADE A CRACKING SOUND. DEVICE WAS REMOVED AND REPLACEMENT WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL ROUND TIP TISSUE SEALING DEVICE GEI ETHICON ENDO-SURGERY NA G4TX7G

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR