BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA NEEDLE DRIVER INSTRUMENT

    MDR report key: 3143551 · Received June 3, 2013

    Report

    Report Number
    2955842-2013-01960
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 16, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. RECEIVED THE INSTRUMENT INVOLVED WITH THE COMPLAINT. ENGINEERING DID NOT CONFIRM THE ALLEGED COMPLAINT. THE INSTRUMENT WAS PLACED ON AN IN HOUSE DA VINCI SYSTEM: RECOGNITION AND ENGAGEMENT TESTS PASSED. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. ADDITIONAL OBSERVATIONS NOT REPORTED BY THE CUSTOMER WERE MAIN TUBE AND PULLEY DAMAGES. THE DISTAL END OF THE MAIN TUBE HAD A SCRATCH MARK SHOWING LIGHT MATERIAL REMOVAL. THE SCRATCH WAS SHORT IN LENGTH AND NOT AXIALLY ALIGNED WITH THE MAIN TUBE. THERE WAS ALSO AN INDENTATION AT THE EDGE OF THE DISTAL PULLEY AND SCRATCHES ON THE SURFACE OF THE PULLEY. EVIDENCE NOT CONCLUSIVE, BUT MAIN TUBE AND PULLEY 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 MAIN TUBE SCRATCHES IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE MEGA NEEDLE DRIVER REPORTEDLY WAS NOT MOVING INTUITIVELY WITH THE SURGEON'S CONTROLS. NOTHING REPORTEDLY FELL INTO A PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244187 MEGA NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420194-08 M10130201 697

    Patients

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