BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 19568055 · Received June 19, 2024

    Report

    Report Number
    2955842-2024-15974
    Event Type
    Malfunction
    Date Received
    June 19, 2024
    Date of Event
    April 26, 2024
    Report Date
    May 22, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114339
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SINGLE-PORT FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE ONE BENT GRIP, CAUSING MISALIGNMENT OF THE GRIPS. THERE WAS A 0.020¿ OFFSET AT THE TIPS. THE GRIPS DO NOT SHOW CRACKING DAMAGE. COMPONENTS ADJACENT TO THIS BENT GRIP SHOW DAMAGE. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT WAS CONNECTED TO THE IN-HOUSE GENERATOR AND PASSED ENERGY RECOGNITION. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS/TIPS (FOR SCISSORS) OPENED AND CLOSED PROPERLY. ENERGY DELIVERY WAS TESTED AND PASSED IN VARIOUS GRIP ORIENTATIONS. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. ADDITIONAL OBSERVATION NOT REPORTED BY SITE: THE INSTRUMENT WAS FOUND TO EXHIBIT THERMAL DAMAGE ON THE MOLDED INSULATOR. .

    Additional Manufacturer Narrative · 0

    THE SINGLE-PORT FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS FURTHER EVALUATED AND THE INITIAL FINDINGS WERE CONFIRMED. THE INSTRUMENT HAD BENT GRIPS AND THERMAL DAMAGE ON THE INSTRUMENT'S MOLDED INSULATOR ON THE LOWER GRIP. THE INSTRUMENT'S COMPLAINT OF ENERGY DELIVERY ISSUES WAS NOT CONFIRMED. ADDITIONALLY, THE INSTRUMENT WAS RUN THROUGH THE HI-POT TEST MULTIPLE TIMES AND PASSED REPEATEDLY WITH NO FAILURES OBSERVED WITH THE FURTHER TESTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE SURGEON COMPLAINED THAT THE SINGLE-PORT FENESTRATED BIPOLAR FORCEPS INSTRUMENT DID NOT PROVIDE ANY ENERGY TO CAUTERIZE TISSUE. THE INSTRUMENT WAS REPLACED WITH NEW ONE TO COMPLETE CASE AS PLANNED. INSTRUMENT WAS INSPECTED AND NOTICED THAT THE TIP OF THE INSTRUMENT WAS NOT COMPLETELY CLOSED. THERE WAS A GAP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677872 ENDOWRIST SP FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430011-57 U10230821 0009 00886874114339

    Patients

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