BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 18234210 · Received November 29, 2023

    Report

    Report Number
    2955842-2023-20677
    Event Type
    Malfunction
    Date Received
    November 29, 2023
    Date of Event
    October 31, 2023
    Report Date
    November 1, 2023
    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) RECEIVED THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT FOR FAILURE ANALYSIS. INSPECTION FOUND THAT THE MBF INSTRUMENT HAD THERMAL DAMAGE AND EXPOSED ELECTRODE. CHARRING AND LOCALIZED MELTING ON THE BIPOLAR YAW PULLEY WAS IDENTIFIED. THE THERMAL DAMAGE WAS DISCOVERED AT THE BASE OF THE YAW PULLEY NEAR THE GRIP, RESULTING IN THE ELECTRODE BEING EXPOSED. AFTER MANUALLY MANIPULATION OF THE MBF GRIPS, THE MBF PASSED AN ELECTRICAL CONTINUITY TEST ON MULTIPLE ATTEMPTS. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A LIVER RESECTION SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT TIP ALLEGEDLY "SPARKED AND BURNED." THE USER CONTINUED THE PROCEDURE USING THE BACKUP INSTRUMENT WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INTO THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MBF INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY THAT WAS NOTED. THE CUSTOMER OBSERVED THAT ARCING AND THERMAL DAMAGE HAD OCCURRED. THE ARCING APPEARED TO HAVE GENERATED WITHIN THE MBF INSTRUMENT JAWS DURING CAUTERIZATION OF THE PARENCHYMA ORGAN. WHEN THE REPORTED EVENT OCCURRED, BIPOLAR ENERGY WAS ACTIVATED. THE SURGEON BELIEVES THAT THE ARCING EVENT OCCURRED DUE TO THE ELECTROCAUTERY WAS OUT OF INDICATION. THE MBF INSTRUMENT WAS CONNECTED PROPERLY, AND THE INTEGRATED ELECTRICAL SURGICAL UNIT (IESU) WAS BEING USED. THE ENERGY SETTINGS ON THE GENERATOR WERE "FORCED COAG EFFECT 4.5." THE MBF INSTRUMENT HAD BEEN IN USE FOR THREE HOURS ALONG WITH THE CADIERE FORCEPS INSTRUMENT, 30 DEGREE ENDOSCOPE AND FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THE MBF TIPS DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR TOOL DURING THE SURGICAL PROCEDURE. THE MBF INSTRUMENT TIP DID NOT TOUCH ANY STAPLES, CLIPS, OR SUTURES WHILE ENERGIZED. THE JAWS OF THE MBF INSTRUMENT WERE NOT IMMERSED IN LIQUID OR CONTAMINATED BY CARBONIZED TISSUE (BIO DEBRIS) PRIOR TO ACTIVATING THE MBF INSTRUMENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS AS A RESULT OF THE ARCING EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2137082 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-17 K11221016 0503 00886874119792

    Patients

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