BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 8384427 · Received March 2, 2019

    Report

    Report Number
    2955842-2019-10155
    Event Type
    Malfunction
    Date Received
    March 2, 2019
    Date of Event
    January 22, 2019
    Report Date
    February 4, 2019
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K112263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING SECTIONS: DATE OF REPORT, CONCOMITANT MEDICAL PRODUCTS , PMA/510K, AND IF FOLLOW-UP, WHAT TYPE. (B)(4) - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS COULD NOT CONFIRM THE CUSTOMER REPORTED FAILURE. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE TIP OPENED AND CLOSED PROPERLY. THE INSTRUMENT WAS FULLY FUNCTIONAL. VISUAL INSPECTION FOUND NO OBVIOUS DAMAGE TO THE INSTRUMENT. 4315 - THE TIP COVER ACCESSORY HAS NOT BEEN RETURNED TO INTUITIVE SURGICAL, INC. FOR FAILURE ANALYSIS EVALUATION BECAUSE IT WAS DISCARDED AT THE SITE. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    REFER TOADDITIONAL FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    THE TIP COVER ACCESSORY HAS NOT BEEN RETURNED TO INTUITIVE SURGICAL, INC. FOR FAILURE ANALYSIS EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER NOTED ARCING OCCURRED FROM THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TO THE FENESTRATED BIPOLAR FORCEPS. THE MCS HAD A TIP COVER AND THE ARCING BURNT A HOLE IN THE FENESTRATED BIPOLAR FORCEPS. ALTHOUGH NO PATIENT HARM OCCURRED, IF THE REPORTED MALFUNCTION WERE TO RECUR, IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER NOTED ARCING OCCURRED FROM THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TO THE FENESTRATED BIPOLAR FORCEPS. THE MCS HAD A TIP COVER AND THE ARCING BURNT A HOLE IN THE FENESTRATED BIPOLAR FORCEPS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177931 NONE TIP COVER ACCESSORY NAY INTUITIVE SURGICAL, INC 400180-14

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI INSTRUMENTS AND ACCESSORIES