BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 2591186 · Received May 24, 2012

    Report

    Report Number
    2134070-2012-00102
    Event Type
    Malfunction
    Date Received
    May 24, 2012
    Report Date
    November 22, 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 WAS BROKE IN TWO PLACES. THE UNATTACHED SECTION OF THE LOOP HAD BEEN RETRIEVED AND WAS RETURNED. IT WAS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE BREAK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY, THE CUTTING LOOP OF AN ENDOSCOPIC ELECTRODE BROKE INTO PIECES. THE BROKEN PIECE WAS RETRIEVED AND RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA ENDOSCOPIC ELECTRODE (NLW) NLW STERILMED, INC. STO27050G

    Patients

    Seq Age Sex Outcome Treatment
    1