BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 19057239 · Received April 8, 2024

    Report

    Report Number
    2955842-2024-13133
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Date of Event
    March 1, 2024
    Report Date
    March 13, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112212
    PMA / PMN Number
    K171426
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE MBF INSTRUMENT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS; HOWEVER, THE EVALUATION IS NOT YET COMPLETE. A FOLLOW-UP MDR WILL BE SUBMITTED ONCE THE PRODUCT IS EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. THE ROOT CAUSE OF THE CUSTOMER-REPORTED FAILURE MODE COULD NOT BE DETERMINED AS THE PRODUCT WOULD NOT BEEN RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE ENDOSCOPE WAS ANALYZED AND THE REPORTED FAILURE WAS CONFIRMED. THE ENDOSCOPE WAS PLACED THROUGH FRICTION TEST USING A SCREENING AID TO MANUALLY ROTATE THE ADAPTER TO DETECT FOR FRICTION. THE CAMERA INSTRUMENT ADAPTER DID NOT ROTATE PROPERLY AND/OR NOISES WERE HEARD DURING TESTING AND CONFIRMED AS BINDING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA TAPP SURGICAL PROCEDURE, THE ENDOSCOPE HAD ROTATIONAL ERRORS GOING UP AND DOWN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED ADDITIONAL INFORMATION THAT THE SURGICAL TASK WAS BEING PERFORMED AT THE TIME OF EVENT UMBILICAL/VENTRAL HERNIA REPAIR. THE IMAGE WAS INVERTED. IT WAS UNKNOWN IF THE ENDOSCOPE MOVED FREELY WITH UNCONTROLLED MOTION OR INVOLVED A REVERSED CONTROL OF SYSTEM ARMS. IT WAS INDICATED THAT THE SURGEON WAS ADVISED TO REMOVE THE ENDOSCOPE IMMEDIATELY. THE ENDOSCOPE WAS INSTALLED AT 30 DEGREES AT THE TIME OF THE EVENT AND WAS IN UP ORIENTATION. THE SURGEON CONFIRMED THE DESIRED ORIENTATION WHEN THE ENDOSCOPE WAS INSTALLED. THE IMAGE ORIENTATION WAS PROVIDED TO THE USER VIA THE USER INTERFACE AND THE ENDOSCOPE¿S ADAPTER WAS ENGAGED. NO DAMAGE WAS OBSERVED ON THE ENDOSCOPE¿S ADAPTER. THE ENDOSCOPE WAS NOT MANUALLY ROTATED 180 DEGREES PRIOR TO THE EVENT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96451 NONE ENDOSCOPE NAY INTUITIVE SURGICAL, INC 470027-62 N/A 00886874112212

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DA VINCI INSTRUMENTS AND ACCESSORIES.