BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 2481555 · Received March 5, 2012

    Report

    Report Number
    2134070-2012-00005
    Event Type
    Malfunction
    Date Received
    March 5, 2012
    Date of Event
    January 1, 2012
    Report Date
    February 6, 2012
    Manufacturer
    STERILMED, INC.
    Product Code
    NUJ
    PMA / PMN Number
    K012598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE THE SURGEON ATTEMPTED TO CAUTERIZE AND THE DEVICE COULD NOT WORK DESPITE DISCONNECTING AND RECONNECTING THE CAUTERY CORD. A NEW DEVICE WAS OPENED AND WORKED. THE PT WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA NUJ STERILMED, INC. ETH5DCS

    Patients

    Seq Age Sex Outcome Treatment
    1