BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE NEEDLE DRIVER INSTRUMENT

    MDR report key: 3626095 · Received February 13, 2014

    Report

    Report Number
    2955842-2014-00855
    Event Type
    Malfunction
    Date Received
    February 13, 2014
    Date of Event
    January 24, 2014
    Report Date
    January 31, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC (ISI) HAS RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER'S REPORTED COMPLAINT OF WOULD NOT RECOGNIZE. FAILURE ANALYSIS WAS ABLE TO REPLICATE THE ISSUE. THE INSTRUMENT FAILED A RTI BOARD RECOGNITION TEST. THE INSTRUMENT WAS CHECKED FOR RECOGNITION ON AN IN-HOUSE IS3000 SYSTEM. THE SYSTEM FAILED TO RECOGNIZE THE INSTRUMENT ON MULTIPLE INSTALLATION ATTEMPTS. AN ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS THAT THE INSTRUMENT PITCH CABLE WAS BROKEN AT THE PROXIMAL END OF THE INSTRUMENT. THE PITCH CABLES WERE LOOSE, BUT NOT VISIBLY BROKEN AT THE WRIST. THE PITCH INPUT SPUN FREELY WITHOUT CORRESPONDING OUTPUT MOTION AT THE DISTAL END, WHICH SUGGESTED A FAILURE AT THE BACKEND. THE HOUSING WAS REMOVED TO FIND ONE GRIP CABLE BROKEN NEAR THE CLAMPING PULLEY CABLE GROOVE. THE CLAMPING PULLEYS EXHIBITED WHITE RESIDUE AROUND THE CABLE GROOVES. THE OTHER BACKEND CABLES WERE NOT DAMAGED. NO OTHER DAMAGES WERE FOUND ON THE INSTRUMENT. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI CHOLECYSTECTOMY PROCEDURE, THE LARGE NEEDLE DRIVER INSTRUMENT WAS NOT RECOGNIZED BY THE SYSTEM. THERE WAS NO HARM TO A PATIENT AND NOTHING FELL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95520 LARGE NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420006-06 M11130218 062

    Patients

    Seq Age Sex Outcome Treatment
    1