BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST PROGRASP

    MDR report key: 3911850 · Received June 19, 2014

    Report

    Report Number
    3911850
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 19, 2014
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A ROBOTIC SURGERY, THE FIRST ASSIST PLACED THE DAVINCI ROBOTIC PROGRASP FORCEPS INTO THE INSTRUMENT ARM PER THE SURGEON'S REQUEST. UPON VIEWING THE TIP OF THE INSTRUMENT HE IMMEDIATELY NOTICED THAT THE CABLE WAS FRAYED AT THE WRISTED JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360294 ENDOWRIST PROGRASP SYSTEM, SURGICAL, COMPUTER NAY INTUITIVE SURGICAL, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR