BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMPHONX

    MDR report key: 10641676 · Received October 7, 2020

    Report

    Report Number
    10641676
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Date of Event
    September 18, 2020
    Report Date
    September 22, 2020
    Manufacturer
    FORTIMEDIX SURGICAL B.V.
    Product Code
    OTJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE CAUTERY ON THE LAP SCISSOR TIPS, THE RESIDENT, NOTICED A BURNED SPOT ON THE LIVER WHERE THEY WERE NOT WORKING. AFTER LOOKING MORE CLOSELY, SHE NOTICED THAT THE END OF THE INSULATION OF THE LAP SCISSOR TIP WAS NOT COMPLETELY INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109797 SYMPHONX LAPAROSCOPIC SINGLE PORT ACCESS DEVICE OTJ FORTIMEDIX SURGICAL B.V. HUB CAP SEALING UNIT 00152698

    Patients

    Seq Age Sex Outcome Treatment
    1 Other