BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 18261442 · Received December 4, 2023

    Report

    Report Number
    2955842-2023-20866
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    November 8, 2023
    Report Date
    November 8, 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
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) HAD THE CUSTOMER REPOSITION THE FORCE BIPOLAR INSTRUMENT AND THE JAWS RELEASED THE TISSUE. INTUITIVE SURGICAL, INC. (ISI), HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) AND REPORTED THAT THE FORCE BIPOLAR INSTRUMENT APPEARED TO HAVE A BROKEN OR MISPOSITIONED CABLE AND WAS STUCK ON TISSUE. THE FORCE BIPOLAR INSTRUMENT WAS INSTALLED ON ARM 1 OF THE PATIENT SIDE CART (PSC). THE TSE NOTED NO ERRORS ASSOCIATED WITH ENGAGEMENT. TSE HAD CUSTOMER PRESS THE EMERGENCY STOP (ESTOP) AND USE THE INSTRUMENT RELEASE KIT (IRK) TO OPEN THE JAWS. CUSTOMER STATED THE JAWS WERE NOT OPENING. THE TSE HAD THE CUSTOMER RECOVER THE FAULT AND TRIED TO REPOSITION THE INSTRUMENT AND THE INSTRUMENT JAWS RELAXED ENOUGH TO RELEASE THE TISSUE. THE CUSTOMER WAS CONTINUED WITH THE PROCEDURE. THE TSE REQUESTED THAT THE CUSTOMER RETURN THE INSTRUMENT. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION. THE CUSTOMER NOTED THE FORCE BIPOLAR WAS USED TO GRAB A PART OF THE COLON AND WOULD NOT OPEN. THE ROOM CALLED TECHNICAL SUPPORT AND UTILIZED THE "EMERGENCY KEY" BUT IT DID NOT HELP. THE SURGEON ENDED UP TWISTING A BIT AND IT FINALLY RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2028932 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K11230601 0158 00886874120767

    Patients

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