BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 16971900 · Received May 22, 2023

    Report

    Report Number
    2955842-2023-14363
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Date of Event
    February 15, 2022
    Report Date
    February 15, 2022
    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
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE BIPOLAR YAW PULLEY AT THE DISTAL END. BOTH BIPOLAR YAW PULLEYS EXHIBITED LOCALIZED MELTING. NO CONDUCTOR WIRE INSULATION DAMAGE WAS OBSERVED. ELECTRICAL CONTINUITY WAS TESTED AND PASSED. THIS FAILURE IS TYPICALLY ASSOCIATED WITH MISHANDLING/MISUSE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE BIPOLAR YAW PULLEY AT THE DISTAL END. BOTH BIPOLAR YAW PULLEYS EXHIBITED LOCALIZED MELTING. NO CONDUCTOR WIRE INSULATION DAMAGE WAS OBSERVED. ELECTRICAL CONTINUITY WAS TESTED AND PASSED. THIS FAILURE IS TYPICALLY ASSOCIATED WITH MISHANDLING/MISUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE RUBBER AROUND TIP OF THE MARYLAND BIPOLAR FORCEPS WAS BURNT. THE SITE REPLACED THE INSTRUMENT AND COMPLETED THE PROCEDURE AS PLANNED WITH NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE RUBBER AROUND TIP OF THE MARYLAND BIPOLAR FORCEPS WAS BURNT. THE SITE REPLACED THE INSTRUMENT AND COMPLETED THE PROCEDURE AS PLANNED WITH NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720440 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-16 N11200622 0079 00886874119792

    Patients

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