BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST PROGRASP FORCEPS

    MDR report key: 3912507 · Received April 9, 2014

    Report

    Report Number
    3912507
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 9, 2014
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE DAVINCI ROBOT WAS IN THE DOCKED POSITION WITH THE PROGRASP FORCEPS ALREADY INSIDE AND SET. THE PHYSICIAN WAS TRYING TO CONTROL THE INSTRUMENT BUT THE INSTRUMENT WOULD NOT WORK/ARTICULATE. THE PHYSICIAN ASSISTANT WAS ON THE STERILE FIELD ASSISTING WHEN SHE NOTICED ON THE ROBOTIC SYSTEM SCREEN THAT THE WIRE ON THE INSTRUMENT WAS LOOSE. THIS INSTRUMENT WAS REMOVED FROM THE ROBOT ARM AND REPLACED WITH NEW PROGRASP FORCEPS. THE PROCEDURE WAS COMPLETED WITHOUT HARM TO PATIENT. UPON INSPECTION, NOTICED THAT THE WIRE IS INDEED LOOSE ALREADY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214329 ENDOWRIST PROGRASP FORCEPS SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *