BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21982484 · Received May 8, 2025

    Report

    Report Number
    2955842-2025-19718
    Event Type
    Malfunction
    Date Received
    May 8, 2025
    Date of Event
    April 9, 2025
    Report Date
    April 17, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112380
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT; HOWEVER, FAILURE ANALYSIS IS STILL ONGOING. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE 8 MM LARGE HEM-O-LOK LARGE CLIP APPLIER INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT WAS ANALYZED AND WAS FOUND TO HAVE GRIP INPUT DISK #7 BROKEN INSIDE THE HOUSING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE 8MM LARGE HEM-O-LOK LARGE CLIP APPLIER INSTRUMENT WAS LOADED CORRECTLY, INSERTED INTO TROCAR, LOCKED INTO THE ARM. THE INSTRUMENT WAS INSERTED INTO THE ABDOMEN OPENED THE APPLIER AND IT WOULD NOT CLOSE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: CUSTOMER CLARIFIED AS THEY SPOKE WITH THE TECH IN DEPTH. THE HEMOLOK WAS USED ONCE SUCCESSFULLY, WAS REMOVED FROM THE PATIENT AND RELOADED. ON SECOND CLIP APPLICATION IT WAS INSERTED AND THE ARM DIDN'T FLASH GREEN TO ADVANCE. ANOTHER INSTRUMENT (NON-HEMOLOK) WAS INSERTED AND THE GREEN INDICATOR LIGHT FLASHED TO ADVANCE. THAT INSTRUMENT WAS REMOVED AND THE HEMOLOK WAS INSERTED AND THE INDICATOR LIGHT FLASHED AND THE INSTRUMENT WAS ADVANCED. ONCE INSIDE THE ABDOMEN, THE SURGEON TOOK CONTROL OF THE INSTRUMENT BUT COULD NOT MOVE IT OR CONTROL IT IN ANY WAY. IT WAS REMOVED AND THE CASE WAS FINISHED WITH THE REGULAR LAPAROSCOPIC HEMOLOK. THE HEMOLOK HAD WORKED ON THE FIRST VESSEL, AND WHEN REMOVED TO RELOAD IT DIDN'T WORK. THE INSTRUMENT WAS SENT OUT. THERE WASN'T ANY PICTURES TAKEN.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760765 ENDOWRIST LARGE HEM-O-LOK CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470230-12 K10220803 0074 00886874112380

    Patients

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