BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE NEEDLE DRIVER INSTRUMENT

    MDR report key: 3073166 · Received April 23, 2013

    Report

    Report Number
    2955842-2013-01351
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 27, 2013
    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 THE INSTRUMENT WAS FOUND WITH A FRAYED GRIP CABLE AT DISTAL END. THE FRAYED STRANDS STUCK OUT AT THE WRIST. OTHER CABLES AT WRIST ARE NOT DAMAGED. ENGINEERING ALSO FOUND INDENTATIONS ON THE EDGES AND WEAR MARKS OF THE DISTAL PULLEY. ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS MAIN TUBE DAMAGE. THE DISTAL END OF THE MAIN TUBE EXHIBITED VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. THE SCRATCHES WERE SHORT IN LENGTH AND WERE NOT ALIGNED WITH THE TUBE AXIS. ENGINEERING CONCLUDED THAT DAMAGE WAS LIKELY DUE TO MISHANDLING. 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 PRIOR TO STARTING A DA VINCI S SURGICAL PROCEDURE, THE CUSTOMER NOTED A DAMAGE WIRE ON THE LARGE NEEDLE DRIVER INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173605 LARGE NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420006-06 M10121128 710

    Patients

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