BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21904618 · Received April 24, 2025

    Report

    Report Number
    2955842-2025-16751
    Event Type
    Malfunction
    Date Received
    April 24, 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
    FR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THAT THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT BE RETURNED FOR FAILURE ANALYSIS TESTING. AS OF THE DATE OF THIS REPORT, THE PRODUCT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL INC., (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) AS A PART OF PREVENTATIVE MAINTENANCE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL INC., (ISI) DID RECEIVE AN INTEGRATED ELECTROSURGICAL UNIT (IESU) INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE ERBE WAS INSTALLED ON AN IN-HOUSE SYSTEM WHERE THE UNIT FUNCTIONED AS EXPECTED. THE UNIT ENERGIZED AND CAUTERIZED AND ALL PORTS RECOGNIZED INSTRUMENTS. THERE WAS NO DATA IN THE ERROR LOG TO INDICATE THAT THE FAULT HAD OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, A NURSE CALLED IN TO REPORT THAT WHEN USING THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT, IT WAS ARCING. PRIOR TO THE CALL, THEY ALREADY USED A NEW INSTRUMENT AND NEW CABLE WITH NO CHANGE. SHE STATED THAT THIS ALREADY HAPPENED ON LAST WEEK. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED LIVE LOGS BUT FOUND NOTHING RELEVANT. THE TSE HAD THE CUSTOMER VERIFY THE LOT NUMBER TO CHECK IF IT WAS THE SAME. ONE OF THEM WAS THE SAME BUT THE OTHER WAS NOT. SO THIS BEHAVIOR WAS ONLY AND ALWAYS HAPPENING WITH THE MBF INSTRUMENT. THE TSE HAD THE CUSTOMER SWAP THE INSTRUMENT AND THE UNIVERSAL SURGICAL MANIPULATOR (USM) ARMS BUT THE CUSTOMER ELECTED NOT TO PERFORM THE TROUBLESHOOTING. THEY WERE USING THE BIPOLAR FORCEPS INSTRUMENT FOR NOW TO COMPLETE THE PROCEDURE. THE POWER AND THE SETTING WERE WAS NORMAL. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORT OF PATIENT INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476804 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-17 K11221212 0227 00886874119792

    Patients

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