BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 16001786 · Received December 18, 2022

    Report

    Report Number
    2955842-2022-16027
    Event Type
    Malfunction
    Date Received
    December 18, 2022
    Date of Event
    October 11, 2022
    Report Date
    October 24, 2022
    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
    MT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING BLACK CORD WAS FRAYED AT THE TIP, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE DAMAGE TO THE CONDUCTOR WIRE¿S INSULATION. VISUAL INSPECTION FOUND THE WIRE EXPOSED. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TEST. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT RELEASED INTERMITTENT ENERGY. THE INSTRUMENT WAS NOT FULLY FUNCTIONAL. THE COMPLAINT REGARDING BLACK CORD WAS FRAYED AT THE TIP WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE OF DAMAGED CONDUCTOR WIRE INSULATION IS ATTRIBUTED TO CARBONIZED TISSUE ON THE GRIPS OF THIS BIPOLAR INSTRUMENT CREATING A CONDUCTIVE PATH DURING USE. THERMAL DAMAGE CAN ALSO RESULT DUE TO INADVERTENT ENERGY APPLICATION FROM A MONOPOLAR INSTRUMENT. THIS ISSUE CAN BE RESOLVED BY USING AN ALTERNATE INSTRUMENT TO COMPLETE THE PROCEDURE. THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD CONDUCTOR WIRE DAMAGE. FAILURE ANALYSIS CONFIRMED THE INSULATION ON THE CONDUCTOR WIRE WAS DAMAGED AND THE CONDUCTOR WIRE WAS EXPOSED AS A RESULT. THE DAMAGED/BROKEN CONDUCTOR WIRE HAS POTENTIAL FOR ELECTRICAL DISCHARGE AT A LOCATION OTHER THAN INTENDED. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BLACK CORD WAS FRAYED AT THE TIP OF A FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THERE WAS NO REPORT OF INJURY TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL DETAILS RELATED TO THE EVENT. THE ONLY INFORMATION THAT WAS PROVIDED BY THE CUSTOMER WAS THAT THERE WAS NO DEATH THAT OCCURRED AS A RESULT THE DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2710201 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 K11220530 0316 00886874119808

    Patients

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