BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERCUT METZENBAUM SCISSOR

    MDR report key: 5204273 · Received November 2, 2015

    Report

    Report Number
    MW5057692
    Event Type
    Malfunction
    Date Received
    November 2, 2015
    Date of Event
    October 5, 2015
    Report Date
    October 16, 2015
    Manufacturer
    BOSS INSTRUMENTS LTD
    Product Code
    MDM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    0

    Narratives

    Description of Event or Problem · 1

    SURGEON ATTEMPTED TO USE LAPAROSCOPIC SCISSORS DURING PROCEDURE TO CUT TISSUE. WHEN COAGULATION WAS ATTEMPTED, A SPARK WAS SEEN COMING FROM BELOW THE SCISSOR PORTION OF THE INSTRUMENT SENDING A SPARK INTO THE PELVIC REGION. THE INSTRUMENT WAS IMMEDIATELY REMOVED AND INSPECTED. UPON INSPECTION IS WAS NOTED A POSSIBLE DEFECT IN THE SHEATH RIGHT BELOW THE SCISSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725246 SUPERCUT METZENBAUM SCISSOR SUPERCUT METZENBAUM SCISSOR MDM BOSS INSTRUMENTS LTD 37-1023

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR