BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAPAROSCOPIC TISSUE SEALER

    MDR report key: 3973005 · Received July 29, 2014

    Report

    Report Number
    MW5037535
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 22, 2014
    Manufacturer
    ETHICON-ENDO SURGERY INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LAPAROSCOPIC TISSUE SEALER JAWS MISALIGNED. NO HARM TO PATIENT. MANUFACTURER: PLEASE NOTE THAT WE DO NOT SENT PRODUCTS TO THE MANUFACTURER, BUT YOU MAY ARRANGE FOR PICK-UP BY CALLING BY NUMBER BELOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441660 LAPAROSCOPIC TISSUE SEALER TISSUE SEALER GEI ETHICON-ENDO SURGERY INC. NSLG45 L4EF5P

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention