BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP (TM) FORCEPS

    MDR report key: 2924100 · Received January 22, 2013

    Report

    Report Number
    2955842-2013-00254
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 27, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT ONE GRIP CLOSE CABLE WAS FOUND TO BE DERAILED AT THE IDLER PULLEY. THE GRIPS WERE STILL ABLE TO OPEN AND CLOSE WITH CLICKING SNAP SOUNDS, BUT THEIR MOVEMENT COULD NOT BE PRECISE. THE CABLE DERAILMENT WAS LIKELY DUE TO THE CABLE LOSING CONTACT WITH THE PULLEY DURING WRIST ARTICULATION. FLEET ANGLE BETWEEN PROXIMAL AND DISTAL PULLEYS COULD HAD CONTRIBUTED TO THE CABLE DERAILMENT. ADDITIONAL OBSERVATION NOT REPORTED BY THE SITE WAS MAIN TUBE INSULATION DAMAGE. THE DISTAL END OF THE MAIN INSULATION TUBE EXHIBITED VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL, SUGGESTING THAT THEY MAY HAVE BEEN CAUSED BY INSTRUMENT COLLISIONS OR ROUGH HANDLING. 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. 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 DURING A DAVINCI SI HYSTERECTOMY PROCEDURE, THE CABLE SNAPPED 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
    31145 PROGRASP (TM) FORCEPS ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10121107 749

    Patients

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