BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3444124 · Received November 1, 2013

    Report

    Report Number
    2955842-2013-04907
    Event Type
    Malfunction
    Date Received
    November 1, 2013
    Date of Event
    September 11, 2013
    Report Date
    October 3, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013 THE DISTRIBUTOR REPRESENTATIVE INSPECTED THE INSTRUMENT AND CONFIRMED A CABLE WAS DERAILED. THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INSPECTED THE INSTRUMENT UNDER MAGNIFICATION FOR DAMAGED OR DERAILED CABLES. NO DERAILED OR DAMAGED CABLES WERE FOUND. THE INSTRUMENT WAS ALSO PLACED ON A DA VINCI IS3000 SYSTEM. THE INSTRUMENT PASSED BOTH THE INSTRUMENT ENGAGEMENT AND INSTRUMENT RECOGNITION TESTS. AN ADDITIONAL FINDING WAS VARIOUS SCRATCHES ON THE DISTAL END OF THE MAIN TUBE SHOWING LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. THE SCRATCHES WERE .062 - .140 IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. FAILURE ANALYSIS CONCLUDED THE DAMAGE MAY BE DUE TO MISHANDLING / MISUSE. NO OTHER DAMAGE WAS FOUND. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; TUBE ABRASIONS WITH MATERIAL REMOVED ,FOUND DURING FAILURE ANALYSIS EVALUATION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI PROSTATECTOMY PROCEDURE, THE SURGEON FELT A BAD FEELING OF OPEN/CLOSE MOVEMENT OF THE PROGRASP FORCEPS INSTRUMENT. THE SURGICAL STAFF CHECKED IT, AND FOUND A WIRE COMING OFF THE PULLEY. THE STAFF EXCHANGED IT INTO A BACKUP INSTRUMENT, AND THE PLANNED PROCEDURE WAS COMPLETED WITHOUT PROBLEM. 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
    564557 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10130220 328

    Patients

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