BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE DRIVER INSTRUMENT

    MDR report key: 3110135 · Received May 13, 2013

    Report

    Report Number
    2955842-2013-01652
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Date of Event
    March 21, 2013
    Report Date
    April 15, 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 THREE OF FOUR HOUSING SNAP TABS AND ALL FOUR ADJACENT HOUSING PINS WERE BROKEN ON THE INSTRUMENT'S BLUE HOUSING. THE HOUSING COULD BE REMOVED AS A RESULT OF THE DAMAGE. ENGINEERING CONCLUDED THAT DAMAGE WAS LIKELY DUE TO MISHANDLING. ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS MAIN INSULATION TUBE DAMAGE. THE DISTAL END OF THE MAIN TUBE EXHIBITED DEEP SCRATCHES WITH MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. 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 GASTRIC BYPASS PROCEDURE, THE SCRUB NURSE NOTICED THAT THE HOUSING OF THE NEEDLE DRIVER INSTRUMENT WAS DAMAGED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211588 NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420117-04 S10100616 175

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES