BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20392182 · Received October 7, 2024

    Report

    Report Number
    2955842-2024-20205
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    September 3, 2024
    Report Date
    September 12, 2024
    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
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS ISSUED A RETURN MATERIAL AUTHORIZATION (RMA) TO HAVE THE INTUITIVE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE PRODUCT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ISI REVIEWED THE CUSTOMER'S PROVIDED IMAGE AND OBTAINED ADDITIONAL INFORMATION: THE GRIP TANG APPEARS TO BE DISLODGED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FORCE BIPOLAR INSTRUMENT WAS ANALYZED AND THE COMPLAINT WAS NOT CONFIRMED. THE INSTRUMENT UNDERWENT EXTERNAL AND INTERNAL VISUAL INSPECTION, AND NO ISSUES DETECTED. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS/TIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT PASSED ALL FUNCTIONAL TESTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE FORCE BIPOLAR INSTRUMENT WOULD SUDDENLY NO LONGER WORK. THE SITE COULD NOT STRAIGHTEN IT OUT AND HAD TO PERFORM A CONTROLLED VISUAL REMOVAL OF THE INSTRUMENT AND TROCAR. THE CUSTOMER STATED THAT IT SEEMED AS IF THE JAW OF THE INSTRUMENT HAD LOOSENED/JUMPED OFF. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO FRAGMENT FELL INTO THE PATIENT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225116 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K12240118 0385 00886874120767

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES