BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP (TM) FORCEPS

    MDR report key: 2862849 · Received December 10, 2012

    Report

    Report Number
    2955842-2012-01208
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 9, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED FAILURE MODE. INSTRUMENT WAS PLACED ON IN-HOUSE DAVINCI ROBOTIC SYSTEM AND IT WAS DRIVEN WITH NO PROBLEM. INSTRUMENT PASSED RECOGNITION AND ENGAGEMENT TESTS. INSTRUMENT WAS ABLE TO MOVE INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS WERE ABLE TO OPEN AND CLOSE PROPERLY. ADDITIONAL OBSERVATION NOT REPORTED BY CUSTOMER WAS A FRAYED GRIP CABLE. THE FRAYED GRIP CABLE WAS LOCATED AT THE DISTAL IDLER PULLEY. THE FRAYED CABLE SECTIONS WERE IN VARIOUS LENGTHS STICKING OUT AT THE WRIST. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DAVINCI SI SURGICAL PROCEDURE, THE CUSTOMER NOTED THAT 'TIPS WON'T OPEN OR CLOSE' ON THE PROGRASP FORCEPS INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRASP (TM) FORCEPS ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10120627 992

    Patients

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