BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 17013703 · Received May 26, 2023

    Report

    Report Number
    2955842-2023-14605
    Event Type
    Malfunction
    Date Received
    May 26, 2023
    Date of Event
    March 26, 2023
    Report Date
    May 4, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114322
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE INSTRUMENT WAS DAMAGED, 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 SINGLE-PORT MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE THERMAL DAMAGE ON THE SURFACE OF THE MOLDED INSULATION. CHAR MARKS WERE OBSERVED. THE ELECTRICAL CONTINUITY TEST PASSED. THE WIRE INSULATION WAS NOT DAMAGED. INSTRUMENT WAS PLACED ON SYSTEM AND PASSED THE RECOGNITION AN ENGAGEMENT TEST. THE INSTRUMENT MOVED INTUITIVELY. THE GRIPS OPENED AND CLOSED PROPERLY AND PERFORMED GRIP FUNCTION SUCCESSFULLY. A BIPOLAR ENERGY CORD WAS SUCCESSFULLY CONNECTED TO GENERATOR AND INSTRUMENT. AN ENERGY ACTIVATION TEST WAS THEN CONDUCTED ON SYSTEM. A WET SPONGE WAS HELD BETWEEN GRIPS AT VARIOUS ANGLES AND BEGAN TO SMOKE WHEN ENERGY PEDAL WAS PRESSED. STEAM GENERATION FROM THE SPONGE INDICATED ACTIVE POWER AND COMPLETE CIRCUIT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE IT WAS DISCOVERED THAT THE SINGLE-PORT MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS DAMAGED. THE INSTRUMENT WAS REPORTEDLY NOT USED ON A PATIENT. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1576052 ENDOWRIST SP MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430010-52 S10210114 0005 00886874114322

    Patients

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