BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21267788 · Received January 29, 2025

    Report

    Report Number
    2955842-2025-00991
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Date of Event
    January 9, 2025
    Report Date
    January 10, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS ISSUED A RETURN MATERIAL AUTHORIZATION (RMA) TO HAVE THE INTUITIVE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIPOLAR FORCEPS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATODUODENECTOMY SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT A SPARK WAS OBSERVED NEAR THE WRIST OF THE MARYLAND BIPOLAR FORCEPS INSTRUMENT. THE CUSTOMER REVIEWED THE RECORDER AND CONDUCTED THAT THE ISSUE WAS LIKELY DUE TO TISSUE AT THE TIP AND EXTENDED ACTIVATION. THE INSTRUMENT WAS REMOVED AND REPLACED WITH A BACKUP. FOLLOWING THIS, THE CUSTOMER CONTINUED AND COMPLETED THE PROCEDURE WITH NO FURTHER ISSUES. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT THE MARYLAND BIPOLAR FORCEPS (MBF)'S GRIP BASE WAS BURNT. THE CANNULA WAS INSPECTED BEFORE USE, AND THE GAUGE PIN PASSED THROUGH THE CANNULA WITHOUT ISSUES. THE ARCING OCCURRED FROM THE BASE OF THE GRIP WHILE THE USER WAS CAUTERIZING AND DISSECTING TISSUES. THE ARCING OCCURRED DURING THE BIPOLAR CUT MODE, AND THE SETTING VALUES WERE NOT PROVIDED. THE USER CONFIRMED THAT THE INSTRUMENT WAS CONNECTED PROPERLY AND THAT A VIO3 GENERATOR WAS USED. THE INSTRUMENT WAS USED FOR 2 OR 3 HOURS BEFORE THE ARCING EVENT. A FENESTRATED BIPOLAR FORCEPS, A 30-DEGREE ENDOSCOPE PLUS, A MARYLAND BIPOLAR FORCEPS, AND A TIP-UP FENESTRATED GRASPER INSTRUMENT WERE USED WHEN THE ARCING OCCURRED. THE MBF DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. THE INSTRUMENT WAS SLIGHTLY ATTACHED BUT NOT IN DIRECT CONTACT WITH THE TISSUE. THE INSTRUMENT TIP(S) DID NOT TOUCH ANY STAPLES, CLIPS, OR SUTURES WHILE ENERGIZED. THE REPORTER CONFIRMED THAT SOME PIECES OF TISSUE WERE ATTACHED TO THE INSTRUMENT'S TIP PRIOR TO ACTIVATING THE INSTRUMENT. THE SURGEON THINKS THAT IT MIGHT BE CAUSED BY THE ADHESION OF TISSUE PIECES OR THE VOLTAGE OF A THIRD-PARTY ELECTRIC SCALPEL. THERE WAS NO PATIENT INJURY, AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830996 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-17 K11240104 00886874119792

    Patients

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