BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 17056497 · Received June 2, 2023

    Report

    Report Number
    2955842-2023-15643
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    April 19, 2023
    Report Date
    May 7, 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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A SPARK FROM THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE MBF HAS NOT YET BEEN RETURNED TO ISI FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT YET BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. 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) RECEIVED THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF INSTRUMENT BIPOLAR YAW PULLEY/THERMAL DAMAGE BETWEEN GRIPS TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE CHARRING AND LOCALIZED MELTING AT THE GRIP BASE BETWEEN THE GRIPS. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT MOVED INTUITIVELY IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT DELIVERED ENERGY ON SEVERAL ATTEMPTS. COMMON CAUSES OF THE FAILURE MODE THERMAL DAMAGE BETWEEN GRIPS INSTRUMENT BIPOLAR YAW PULLEY ARE TYPICALLY ATTRIBUTED TO MISHANDLING/MISUSE OF THE DEVICE FOR EXAMPLE BY INSULATION DEGRADATION AND CARBONIZED TISSUE CREATING A CONDUCTIVE PATH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL HYSTERECTOMY SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT SPARKED. THE CUSTOMER USED A NEW MBF INSTRUMENT TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC.(ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MBF INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ISSUE. THERE WAS NO DAMAGE TO THE INSTRUMENT AFTER THE ARCING EVENT. THE CANNULA WAS INSPECTED PRIOR TO USE WITH GAUGE PIN WITH NO ISSUE. THE CUSTOMER STATED THE MBF TIPS WERE IN CONTACT DISSECTING TISSUE WHEN THE ARCING EVENT OCCURRED. THE CUSTOMER STATED THERE WAS NO PATIENT INJURY. ENERGY WAS ACTIVATED WITH VIO3 GENERATOR, AND THE BIPOLAR CORD WAS CONNECTED TO THE GENERATOR PROPERLY. THE MBF INSTRUMENT WAS USED ABOUT THREE HOURS PRIOR TO THE ARCING EVENT. CARDIERE FORCEPS AND SYNCHROSEAL INSTRUMENTS WERE IN USE WHEN THE ARCING EVENT OCCURRED, AND THE TIPS OF THE MBF INSTRUMENT COLLIDED WITH THESE INSTRUMENTS. THE INSTRUMENT TIPS DID NOT TOUCH ANY STAPLES, CLIPS OR SUTURES WHILE BEING ENERGIZED. IT WAS POSSIBLY THAT THE MBF INSTRUMENT JAWS WERE IMMERSED IN LIQUID OR CONTAMINATED BY CARBONIZED TISSUE (BIO DEBRIS) PRIOR TO ACTIVATING THE INSTRUMENT. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS BECAUSE OF THE ARCING EVENT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1410635 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-17 K11220725 0272 00886874119792

    Patients

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