BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST STABILIZER INSTRUMENT

    MDR report key: 3173969 · Received June 17, 2013

    Report

    Report Number
    2955842-2013-02200
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    December 6, 2012
    Report Date
    May 21, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K080291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE REPORTED COMPLAINT. THE PITCH CABLE WAS FRAYED. THE PITCH DOWN CABLE WAS FRAYED AT THE DISTAL CLEVIS HUB. THE FRAYED STRANDS STUCK OUT AT THE INSTRUMENT'S WRIST. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DA VINCI S CARDIAC PROCEDURE NURSE CHECKED THE ENDOWRIST STABILIZER INSTRUMENT'S FUNCTION AND FOUND A PART OF THIS PRODUCT WAS BROKEN. THERE WERE NO MISSING PIECES OR FALLEN PIECES REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273090 ENDOWRIST STABILIZER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420182-07 S10110613 418

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES