BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST;DAVINCI SI

    MDR report key: 16971500 · Received May 21, 2023

    Report

    Report Number
    2955842-2023-14088
    Event Type
    Malfunction
    Date Received
    May 21, 2023
    Date of Event
    March 2, 2021
    Report Date
    March 3, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874111642
    PMA / PMN Number
    K050369
    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 FENESTRATED BIPOLAR FORCEPS (FBP) INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF BURNT TIP TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE FBF INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE YAW PULLEY. THE CONDUCTOR WIRE WAS NOT DAMAGED. THE INSTRUMENT PASSED AN ELECTRICAL CONTINUITY TEST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DISTAL GASTRECTOMY SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT TIP WAS FOUND TO BE BURNT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870821 ENDOWRIST;DAVINCI SI FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 420205-16 N10200615 596 00886874111642

    Patients

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