BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3760009 · Received April 18, 2014

    Report

    Report Number
    2955842-2014-02376
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    January 27, 2014
    Report Date
    April 2, 2014
    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

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS FOUND THE INSTRUMENT'S GRIP CABLE TO BE DERAILED. THE INSTRUMENT COULD NOT BE PLACED ON AN IN-HOUSE DA VINCI SYSTEM DUE TO THE INSTRUMENT BEING EXPIRED. THE INSTRUMENT WAS TESTED MANUALLY AND ONE OF THE GRIP CABLE DID NOT MOVE SMOOTHLY. THE HOUSING WAS OPENED TO FIND THAT ONE OF THE GRIP CABLE WAS DERAILED FROM THE CLAMPING PULLEY. MOTION MIGHT NOT BE PRECISE OR SMOOTH DUE TO CABLE DERAILMENT. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE INSTRUMENT'S PITCH UP CABLE TO BE FRAYED AT THE DISTAL CLEVIS HUB. THE OTHER CABLES AT THE WRIST OF THE INSTRUMENT WERE UNDAMAGED. THE INSTRUMENT'S MAIN TUBE HAD SCRATCH MARKS/ABRASIONS. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCHES WITH LIGHT MATERIAL MISSING. NO OTHER DAMAGE FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE FRAYED CABLE AND VARIOUS SCRATCH MARKS ON THE MAIN TUBE WITH LIGHT MATERIAL MISSING FOUND DURING FAILURE ANALYSIS IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI CYSTECTOMY SURGICAL PROCEDURE, THE PROGRASP FORCEPS INSTRUMENT DID NOT RESPOND PROPERLY TO THE MASTER CONTROL MOVEMENTS. THE INSTRUMENT FELT HARD TO THE ENDOWRIST MOVEMENTS. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238384 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M11121101 129

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR