BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSOR

    MDR report key: 1945461 · Received December 21, 2010

    Report

    Report Number
    1945461
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 20, 2010
    Report Date
    December 21, 2010
    Manufacturer
    INTUITIVE SURGICAL INC
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ROBOTIC TOTAL HYSTERECTOMY - MONOPOLAR CURVED SCISSORS WORKED INTERMITTENTLY THROUGHOUT CASE. MONOPOLAR POWER CABLE WAS UNPLUGGED AND REPLUGGED IN TO TRY AND RESOLVE ISSUE. POWER CORD WAS VERY HOT AND LATER BROKE OFF. MONOPOLAR SCISSOR WAS ALSO BROKEN AT THE BASE. NO KNOWN INJURY TO THE PATIENT. THIS ITEM IS A REUSABLE ITEM. THE STAFF IS UNSURE IF THE CORD WAS FRAYED BEFORE THE CASE, OR IF IT HAPPENED DURING THE CASE. THIS EVENT WILL BE FORWARDED TO RISK MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CURVED SCISSOR DAVINCI ENDOWRIST INSTRUMENT NAY INTUITIVE SURGICAL INC 420179 M11100415 642

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR