BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTUITIVE SURGICAL

    MDR report key: 3952660 · Received July 17, 2014

    Report

    Report Number
    MW5037356
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    May 8, 2014
    Report Date
    July 17, 2014
    Manufacturer
    INTUITIVE SURGICAL
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ROBOTIC HYSTERECTOMY, A FENESTRATED BIPOLAR WAS PLACED IN ARM 2 OF THE ROBOT. THE INSTRUMENT TIP WAS MOVING THE OPPOSITE WAY FROM THE DIRECTION THE SURGEON WAS TURNING IT. THE INSTRUMENT WAS REMOVED. IT WAS INSPECTED AND A FRAYED WIRE WAS NOTED AT THE WRIST OF THE DEVICE. INSTRUMENT WAS REPLACED. PHOTOGRAPHS TAKEN, FAULTY INSTRUMENT WAS TAKEN TO STERILE SUPPLY. NO HARM TO PT. INSTRUMENT WAS ON 8TH LIFE - HAD BEEN REPROCESSED. REPORT TO INTUITIVE SURGICAL. INSTRUMENT RETAINED UNTIL AFTER INTUITIVE SURGICAL'S TEAM EVALUATES ON SITE. REASON FOR USE: ROBOTICALLY ASSISTED HYSTERECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420199 INTUITIVE SURGICAL FENESTRATED BIPOLAR FORCEP NAY INTUITIVE SURGICAL VER-05 N10131123616

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention