BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 16883271 · Received May 6, 2023

    Report

    Report Number
    2955842-2023-12624
    Event Type
    Malfunction
    Date Received
    May 6, 2023
    Date of Event
    August 31, 2020
    Report Date
    September 1, 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
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE HAS RECEIVED THE PART ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT "FORCEPS BROKE AT THE TIP AND NAIL JUNCTION, LOSING ALL MOVEMENT DURING THE PROCEDURE." FOR CLARIFICATION, THE INSTRUMENT WAS FOUND TO HAVE THE MAIN TUBE BROKEN. NO MATERIAL WAS FOUND MISSING. THE INSTRUMENT WAS FOUND TO HAVE VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVED ON THE MAIN TUBE. THE SCRATCH MARKS WERE .142¿ - .381 IN LENGTH AND WERE NOT ALIGNED WITH THE TUBE AXIS. THE INSTRUMENT'S' DISTAL CLEVIS WAS FOUND TO HAVE SCRATCH MARKS. THE INSTRUMENT WAS FOUND TO HAVE A SEGMENT OF THE CONDUCTOR WIRE STICKING OUT FROM THE YAW PULLEY. A LOOP OF WIRE IS STICKING OUT SUCH THAT THE WIRE PROTRUDES ABOVE THE OUTER SURFACE OF THE MAIN TUBE. THE WIRE INSULATION WAS NOT DAMAGED, AND THE INSTRUMENT FAILED AN ELECTRICAL CONTINUITY TEST. NO THERMAL DAMAGE WAS OBSERVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INSTRUMENT WAS FOUND TO HAVE A BROKEN TIP. A BACKUP INSTRUMENT WAS USED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555944 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 470172-15 N10171110 0167 00886874112281

    Patients

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