BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 16998945 · Received May 24, 2023

    Report

    Report Number
    2955842-2023-14545
    Event Type
    Malfunction
    Date Received
    May 24, 2023
    Date of Event
    April 26, 2023
    Report Date
    May 1, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119815
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ISSUE. THE INSTRUMENT POSSIBLY COLLIDED WITH THE OTHER INSTRUMENT. THE MOVEMENT OF THE INSTRUMENT WAS DELAYED. THERE WAS NO PATIENT INJURY AS RESULT OF THE EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS DID NOT REPLICATE NOR CONFIRM THE REPORTED COMPLAINT. VISUAL INSPECTION DISPLAYED NO SIGNS OF PHYSICAL DAMAGE. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM AND PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS AND THE GRIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT WAS FULLY FUNCTIONAL. THERE WAS NO PROBLEM DETECTED.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING, NON-INTUITIVE MOTION OF THE MEGA SUTURE CUT NEEDLE DRIVER (MSND) INSTRUMENT. AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE INSTRUMENT WAS RETURNED FOR THE FAILURE ANALYSIS. HOWEVER, THE INVESTIGATION IS IN PROGRESS. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION. THIS COMPLAINT IS CONSIDERED AS A REPORTABLE MALFUNCTION, DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED, THAT THE MEGA SUTURE CUT NEEDLE DRIVER INSTRUMENT MOVED WITH UNINTUITIVE MOTION (E.G. THE INSTRUMENT UNEXPECTEDLY JERKED/JUMPED/SWUNG/BOWED, MOVED IN AN UNEXPECTED/UNINTENDED/UNKNOWN WAY). UNINTUITIVE MOTION COULD LEAD TO SUBSEQUENT TISSUE DAMAGE. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT. THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE. POOR MOVEMENT WAS OBSERVED, WITH THE MEGA SUTURE CUT NEEDLE DRIVER (MSND) INSTRUMENT. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741558 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-15 K10220808 0163 00886874119815

    Patients

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