BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP (TM) FORCEPS INSTRUMENT

    MDR report key: 3103610 · Received May 9, 2013

    Report

    Report Number
    2955842-2013-01580
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 9, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING WAS UNABLE TO CONFIRM THE REPORTED FAILURE MODE. THE INSTRUMENT WAS PLACED ON THE IN-HOUSE DA VINCI ROBOT SYSTEM AND DRIVEN WITHOUT ANY PROBLEM. THE INSTRUMENT PASSED RECOGNITION AND ENGAGEMENT TEST. INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. GRIPS OPENED AND CLOSED PROPERLY. ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS MAIN TUBE DAMAGE. THE DISTAL END OF THE MAIN TUBE EXHIBITED VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE 0.060 - 0.120 IN LENGTH AND WERE NOT ALIGNED WITH THE TUBE AXIS. ENGINEERING CONCLUDED THAT DAMAGE WAS LIKELY DUE TO MISHANDLING. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI S SURGICAL PROCEDURE, IT WAS NOTED THAT THE PROGRASP FORCEPS INSTRUMENT DID NOT OPEN, INSTRUMENT WAS NOT USED IN CASE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203273 PROGRASP (TM) FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M11130118 242

    Patients

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