BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 2955126 · Received February 11, 2013

    Report

    Report Number
    2955842-2013-00457
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 16, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED FAILURE MODE AS THE INSTRUMENT SUCCESSFULLY PASSED RECOGNITION AND ENGAGEMENT TESTING, SHOWING THAT THE INSTRUMENT HAD 1 USE REMAINING WHILE INSTALLED ON AN IS3000 IN-HOUSE SYSTEM. THE POGO PINS DID NOT STICK AND WERE NOT CONTAMINATED. THE INSTRUMENT PASSED (B)(4) TESTING. ADDITIONAL FUNCTIONAL TESTING REVEALED THAT THE INSTRUMENT MOVED INTUITIVELY AND THE GRIPS OPENED AND CLOSED PROPERLY. ENGINEERING EVALUATION ALSO FOUND THAT THE PITCH CABLE AT THE DISTAL IDLER IS FRAYED. THERE WAS NO DAMAGE OBSERVED TO THE PULLEY AND CLEVIS. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE DAMAGE TO THE INSTRUMENT'S PITCH CABLE FOUND DURING FAILURE ANALYSIS COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE MALFUNCTIONS WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI PROSTATECTOMY PROCEDURE, THE PROGRASP FORCEPS INSTRUMENT WAS NOT RECOGNIZED BY THE SYSTEM. THERE WERE NO MISSING 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
    59116 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10121016 490

    Patients

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