BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 16971625 · Received May 22, 2023

    Report

    Report Number
    2955842-2023-14201
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Date of Event
    October 28, 2020
    Report Date
    October 29, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112281
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    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 INVESTIGATION CONFIRMED THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF THERMAL DAMAGE TO THE BIPOLAR YAW PULLEY TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE BIPOLAR YAW PULLEY. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. NO SIGNS OF INSULATION DAMAGE TO THE CONDUCTOR WIRE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED PROSTATECTOMY WITH LYMPH NODE DISSECTION PROCEDURE, THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT APPEARS TO HAVE MELTED AT THE METAL/INSULATION JOINT DUE TO ENERGY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WORKED WITH NO ISSUES DURING SURGERY. THERE WERE NO REPORTS OF ARCING OR INJURY TO THE PATIENT. AFTER THE PROCEDURE WAS ENDED, THE INSTRUMENT WAS INSPECTED AND NOTICED TO HAVE THERMAL DAMAGE. THERE WAS NO CONTACT OF THE INSTRUMENT WITH STAPLES, CLIPS OR METAL OBJECTS AS WELL AS NO COLLISION WITH OTHER INSTRUMENTS OR TOOLS. THERE WAS NO BIO-DEBRIS AT THE INSTRUMENT JAWS WHEN THE INSTRUMENT WAS ACTIVATED AND NO BROKEN CABLE WAS NOTICED. IT WAS CONFIRMED THAT A MONOPOLAR CORD WAS NOT CONNECTED TO THE MBF INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781607 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 470172-16 N11200218 0069 00886874112281

    Patients

    Seq Age Sex Outcome Treatment
    1 Male DA VINCI INSTRUMENTS AND ACCESSORIES