BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 2591228 · Received May 24, 2012

    Report

    Report Number
    2134070-2012-00095
    Event Type
    Malfunction
    Date Received
    May 24, 2012
    Report Date
    October 14, 2011
    Manufacturer
    STERILMED, INC.
    Product Code
    NLW
    PMA / PMN Number
    K012685
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL INVESTIGATION SHOWED THAT THE CUTTING LOOP OF THE DEVICE WAS BROKEN. THE PIECE THAT BROKE OFF WAS RETURNED WITH THE DEVICE. IT WAS NOT POSSIBLE TO DETERMINE WHAT CAUSED THE CUTTING LOOP TO BREAK DURING USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ELECTRODE BROKE DURING A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA ENDOSCOPIC ELECTRODE (NLW) NLW STERILMED, INC. STO27040G

    Patients

    Seq Age Sex Outcome Treatment
    1