BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 17270486 · Received July 6, 2023

    Report

    Report Number
    2955842-2023-16843
    Event Type
    Malfunction
    Date Received
    July 6, 2023
    Date of Event
    June 9, 2023
    Report Date
    June 12, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874120767
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING STUCK ON TISSUE, WOULD NOT RELEASE, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THAT TISSUE WAS STUCK ON THE 8MM FORCE BIPOLAR AND WOULD NOT RELEASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO TISSUE ADHERED TO THE INSTRUMENT. TISSUE WAS GETTING CAUGHT IN THE INSTRUMENT AT THE PULLEY/HINGE. THE SURGEON USED ANOTHER INSTRUMENT TO RELEASE THE TISSUE. NO TISSUE WAS EXCISED DUE TO THE EVENT. THERE WAS NO BLOOD TRANSFUSION, ACCORDING TO THE SURGEON. THE EVENT IMPACTED THE PROCEDURE VIA DELAY AND FRUSTRATION, THE EVENT DID NOT AFFECT THE PATIENTS HEALTH. THERE IS NO CONCERN ABOUT THE EVENT CAUSING ANY LONG-TERM COMPLICATIONS WITH THE PATIENT. THE SURGEON BELIEVES THE EVENT WAS CAUSED WHEN THE PULLEY IN THE FORCE BIPOLAR HAD A PIECE PROTRUDE AND CATCH SOME TISSUE. THERE WAS NO INJURY TO THE PATIENT AND THE PROCEDURE WAS COMPLETED ROBOTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2030483 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K10221204 0251 00886874120767

    Patients

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