BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21716352 · Received March 28, 2025

    Report

    Report Number
    2955842-2025-11831
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Date of Event
    February 27, 2025
    Report Date
    March 4, 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
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE BIPOLAR INSTRUMENT WAS ANALYZED AND FOUND TO HAVE CHARRING AND LOCALIZED MELTING AT THE GRIP BASE BETWEEN THE GRIPS. THE INSTRUMENT DOES NOT SHOW DAMAGE TO THE CONDUCTOR WIRE. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF THERMAL DAMAGE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT SPARKED. THE PROCEDURE WAS CONTINUED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ARCING APPEAR TO ORIGINATE/OCCURRED FROM THE TIP OF THE INSTRUMENT. THE ARC GROUND NEAR THE PATIENT TISSUE. THERE WAS NO DAMAGE TO THE INSTRUMENT / ACCESSORY NOTED AFTER THE ARCING EVENT. LEVER DISSECTION SURGICAL TASK WAS BEING PERFORMED WHEN THE ARCING EVENT OCCURRED. FENESTRATED BIPOLAR AND CADIERE FORCEPS INSTRUMENTS WERE IN USE WHEN THE ARCING EVENT OCCURRED. THE ERBE, VIO (EQUIPMENT INSTALLED IN THIS MACHINE) WAS USED. THE SETTINGS USED ON THE ON THE GENERATOR/ESU WERE SWIFTCOAG EFFECT 2 POWER LIMIT 60W. THE INSTRUMENT WAS USED FOR 4 HOURS PRIOR TO THE ARCING EVENT. THE INSTRUMENT TIP(S) WAS IN CONTACT WITH THE TISSUE WHEN THE ARCHING EVENT OCCURRED. THERE WAS NO INJURY TO THE PATIENT. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS AS A RESULT OF THE ARCING EVENT. THE SURGEON BELIEVED THAT THE FORCEPS MAY HAVE HAD BURNED TISSUE ON THE TIP WHICH CAUSED ARCHING. THE INSTRUMENT / ACCESSORY WAS INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY. THE INSTRUMENT WAS CONNECTED PROPERLY. THE INSTRUMENT TIPS DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING PROCEDURE. THE INSTRUMENT JAWS WERE NOT IMMERSED IN LIQUID OR CONTAMINATED BY CARBONIZED TISSUE (BIO DEBRIS) PRIOR TO ACTIVATING THE INSTRUMENT. THERE WERE NO PHOTOGRAPHIC IMAGES OF THE DEVICE(S) OR A VIDEO RECORDING OF THE PROCEDURE AVAILABLE FOR ISI REVIEW. THE PATIENT INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1603496 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-17 K10230928 0132 00886874119792

    Patients

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