BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3250656 · Received July 26, 2013

    Report

    Report Number
    2955842-2013-02778
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    June 17, 2013
    Report Date
    July 1, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING DID NOT CONFIRM THE REPORTED ISSUE. THE RETURNED INSTRUMENT WAS PLACED ON AN IN HOUSE DA VINCI SYSTEM. THE SYSTEM SUCCESSFULLY RECOGNIZED THE INSTRUMENT. THE POGO PINS DID NOT STICK AND WERE NOT CONTAMINATED. DCP (DALLAS CHIP PROCESSOR) VERIFICATION OF INSTRUMENT PASSED. INSTRUMENT WAS DRIVEN AND MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. GRIPS OPENED AND CLOSED PROPERLY. AN ADDITIONAL OBSERVATION THAT WAS NOT REPORTED BY THE CUSTOMER WAS MAIN TUBE DAMAGE. DISTAL END OF MAIN TUBE HAD FEW SCRATCH MARKS EXHIBITING LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. SCRATCHES WERE SHORT IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. EVIDENCE NOT CONCLUSIVE BUT MAIN TUBE DAMAGE MAY BE DUE TO MISHANDLING. THE INSTRUMENTS & ACCESSORIES 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 REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF TO REOCCUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE, THE SYSTEM WOULD NOT RECOGNIZE THE PROGRASP FORCEPS INSTRUMENT. THE INSTRUMENT WAS NOT USED ON A PATIENT AFTER THE REPORTED ISSUE WAS IDENTIFIED AND THERE WAS NO ALLEGATION OF HARM OR INJURY TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351596 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10130412 350

    Patients

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