BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21972259 · Received May 6, 2025

    Report

    Report Number
    2955842-2025-19292
    Event Type
    Malfunction
    Date Received
    May 6, 2025
    Date of Event
    April 29, 2025
    Report Date
    May 4, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119792
    PMA / PMN Number
    K214095
    Removal / Correction Number
    ISIFA2024-09-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) REQUESTED THAT THE MARYLAND BIPOLAR FORCEPS BE RETURNED FOR FAILURE ANALYSIS INVESTIGATION. ISI HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE 8MM MARYLAND BIPOLAR FORCEPS INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE CHARRING AND LOCALIZED MELTING ON BOTH BIPOLAR YAW PULLEYS, IN THE SPACE BETWEEN THE GRIPS. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. BASED ON ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THE INSTRUMENT INVOLVED WITH THIS COMPLAINT DOES NOT MEET THE CRITERIA FOR ISIFA2024-09-C AS PREVIOUSLY LISTED IN SECTION H9. ANNEX G WAS UPDATED TO REFLECT THE FAILURE ANALYSIS FINDINGS.

    Additional Manufacturer Narrative · 0

    ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THERMAL DAMAGE WAS OBSERVED ON THE INSTRUMENT AND ARCING WAS OBSERVED DURING THE PROCEDURE. WHEN THE ARCING EVENT OCCURRED THE GRASPER INSTRUMENT WAS ALSO IN USE. THE COMPLAINT WAS CAUSED BY THE INSTRUMENT ASSOCIATED WITH THE ISSUE. THE PATIENT DID NOT EXPERIENCE ANY INJURIES AS A RESULT OF THE REPORTED ISSUE NEITHER DURING THE PROCEDURE OR AFTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE WIRES OF THE INSTRUMENT WAS BROKEN DURING PROCEDURE. OCCURRED ON THE 1TH USE. LEFT 13 CREDITS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88583 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-17 K11230907 0301 00886874119792

    Patients

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