BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21913991 · Received April 25, 2025

    Report

    Report Number
    2955842-2025-17041
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    March 31, 2025
    Report Date
    March 31, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119792
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE 8MM MARYLAND BIPOLAR FORCEPS INSTRUMENT TO PERFORM FAILURE ANALYSIS. FAILURE ANALYSIS INVESTIGATIONS DID NOT CONFIRM THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS ANALYZED AND IT WAS FOUND TO BE FULLY FUNCTIONAL. THE INSTRUMENT UNDERWENT VISUAL INSPECTIONS ; MANUAL ARTICULATION TESTS ; RECOGNITION TESTS ; ENERGY DELIVERY TESTS ; MOTION TESTS WITH NO ISSUES TO BE FOUND. THE INSTRUMENT WAS RECOGNIZED AND IT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. IT ALSO PASSED THE ENERGY DELIVERY TEST ALONG WITH ENERGY CONTINUITY TEST IN VARIOUS GRIP ORIENTATIONS.

    Additional Manufacturer Narrative · 0

    THE 8MM MARYLAND BIPOLAR FORCEPS INSTRUMENT INVOLVED IN THIS COMPLAINT HAS NOT BEEN RECEIVED AND/OR TESTED BY FAILURE ANALYSIS AS OF THE DATE OF THIS REPORT. IF THE PRODUCT IS RECEIVED AND EVALUATED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM MARYLAND BIPOLAR FORCEPS INSTRUMENT HAD AN UNKNOWN FAILURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. NO FRAGMENT(S) FELL INTO THE PATIENT'S ANATOMY. INTUITIVE SURGICAL INC., (ISI) FOLLOWED-UP WITH INITIAL REPORTER AND OBTAINED FOLLOWING ADDITIONAL INFORMATION : THE REPORTED 8MM MARYLAND BIPOLAR FORCEPS WAS OBSERVED TO HAVE A BROKEN WIRE AT THE DISTAL TIP. THERE WAS NO MATERIAL MISSING FROM DISTAL END OF THE INSTRUMENT. THE BLACK CABLE ON INSTRUMENT WAS FOUND TO BE BROKEN. CUSTOMER WAS UNAWARE IF THERE WAS AN ARCING EVENT WITH REPORTED INSTRUMENT. THERE WAS NO LOSS OF CAUTERY DURING PROCEDURE. THERE WERE NO ISSUES WITH MOVEMENTS OF INSTRUMENT JAWS. THE INSTRUMENT MOVED IN AN UNINTENDED DIRECTION. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370706 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-17 K11240711 0243 00886874119792

    Patients

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