BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 17276330 · Received July 6, 2023

    Report

    Report Number
    2955842-2023-16874
    Event Type
    Malfunction
    Date Received
    July 6, 2023
    Date of Event
    June 8, 2023
    Report Date
    June 8, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119808
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A BROKEN CONDUCTOR WIRE OF THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT, HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. THE INVESTIGATION TO DETERMINE THE CAUSE OF THIS REPORTED EVENT IS CURRENTLY IN PROGRESS. AS SUCH, THE PROBABLE ROOT CAUSE CANNOT YET BE DETERMINED BASED ON THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT AND HAS COMPLETED THE FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN CONDUCTOR WIRE AT THE DISTAL END. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED RECOGNITION AND ENGAGEMENT TESTS BUT FAILED ELECTRICAL CONTINUITY AND ENERGY DELIVERY TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH A FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. A VISUAL INSPECTION SHOWED NO THERMAL DAMAGE. NO PORTION OF THE CONDUCTOR WIRE INSULATION IS MISSING BUT THE WIRES ARE EXPOSED. THE COMPLAINT REGARDING THE BROKEN CONDUCTOR WIRE WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER-REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH URINARY DIVERSION, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THE BIPOLAR OUTPUT WAS WEAK. THE CUSTOMER HAD REPLACED THE ENERGY CABLE AND INSTRUMENT, BUT THE ISSUE WAS NOT RESOLVED. THE TSE ADVISED THE CUSTOMER TO CHANGE TO ANOTHER TYPE OF INSTRUMENT. AFTERWARDS, THE CUSTOMER NOTICED THAT THE WIRE OF THE INSTRUMENT WAS DAMAGED, AND THE ISSUE WAS RESOLVED AFTER REPLACING THE INSTRUMENT. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT WAS INSPECTED BEFORE THE STERILIZATION WITH NO DAMAGE. IT WAS UNKNOWN IF THE INSTRUMENT COLLIDED WITH ANOTHER OTHER INSTRUMENT OR TOOL. THE BLACK CONDUCTOR WIRE WAS BROKEN COMPLETELY. THERE WAS NO ARCING AND NO SIGN OF THERMAL DAMAGE.

    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
    422159 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 K12220606 0399 00886874119808

    Patients

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