BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP (TM) FORCEPS

    MDR report key: 2921182 · Received January 17, 2013

    Report

    Report Number
    2955842-2013-00229
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 18, 2012
    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. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT A FRAYED GRIP CABLE WAS FOUND AT DISTAL IDLER PULLEY. THE FRAYED GRIP CABLE ALSO BECAME DERAILED AT THE DISTAL IDLER PULLEY. THE IDLER PULLEY RIM EXHIBITED DAMAGE. GRIPS WERE STILL ABLE TO OPEN AND CLOSE, BUT THEIR MOVEMENT AND FUNCTIONALITY COULD NOT BE PRECISE. ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS MAIN INSULATION TUBE DAMAGE. THE DISTAL END OF MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. ENGINEERING CONCLUDED THAT DAMAGE WAS LIKELY DUE TO MISHANDLING. NO OTHER DAMAGE WAS FOUND. 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DAVINCI SI SURGICAL PROCEDURE, THE PROGRASP FORCEPS INSTRUMENT DID NOT WORK ANYMORE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26115 PROGRASP (TM) FORCEPS ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10111109 719

    Patients

    Seq Age Sex Outcome Treatment
    1 32 DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES