BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 19285511 · Received May 10, 2024

    Report

    Report Number
    2955842-2024-14230
    Event Type
    Injury
    Date Received
    May 10, 2024
    Date of Event
    March 6, 2024
    Report Date
    April 10, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112380
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION, BUT ANALYSIS HAS NOT YET BEEN COMPLETED. A SYSTEM LOG REVIEW DID NOT REVEAL ANY SYSTEM ERRORS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT WAS RETURNED TO INTUITIVE SURGICAL, INC. (ISI) AND FAILURE ANALYSIS EVALUATION WAS PERFORMED. THERE WAS NO PROBLEM OR DAMAGE FOUND. THE INSTRUMENT PASSED RECOGNITION AND ENGAGEMENT TESTS, MOVED INTUITIVELY WILL FULL RANGE OF MOTION IN ALL DIRECTIONS, AND THE GRIPS OPENED AND CLOSED PROPERLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY, THE LARGE CLIP APPLIER INSTRUMENT WAS VERY STIFF AND DIFFICULT TO OPEN. AN INJURY WAS REPORTED, BUT NO DETAILS WERE GIVEN. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    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
    2308725 ENDOWRIST LARGE HEM-O-LOK CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470230-12 0368 00886874112380

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Other DA VINCI INSTRUMENTS AND ACCESSORIES