BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 18714195 · Received February 15, 2024

    Report

    Report Number
    2955842-2024-11478
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Date of Event
    October 25, 2023
    Report Date
    January 23, 2024
    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 TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT WAS ANALYZED AND FOUND TO HAVE CHARRING AND LOCALIZED MELTING AT THE GRIP BASE ON THE OUTSIDE OF THE YAW PULLEY. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL WITH LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS (MBF) DISK WAS DAMAGED. THE CUSTOMER USED A BACKUP MBF INSTRUMENT TO CONTINUE WITH THE PLANNED PROCEDURE. NO FRAGMENT FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747533 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-17 K10230219 0047 00886874119792

    Patients

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