BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 16971569 · Received May 22, 2023

    Report

    Report Number
    2955842-2023-14156
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Date of Event
    December 16, 2021
    Report Date
    December 23, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874121511
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF YAW PULLEY THERMAL DAMAGE TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. FOR CLARIFICATION, THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE YAW PULLEY. THE INSTRUMENTS CONDUCTOR WIRE WAS NOT FOUND TO BE DAMAGED. THE INSTRUMENT PASSED AN ELECTRICAL CONTINUITY TEST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE CURVED BIPOLAR DISSECTOR INSTRUMENT WAS FOUND TO HAVE THE COATING STRIPPED. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. DURING THE PROCEDURE, THE PLASTIC PART AT THE TIP WAS FOUND BROKEN. THE CUSTOMER CONFIRMED THAT NO FRAGMENT FELL INSIDE OF THE PATIENT. THERE WAS NO PATIENT INJURY/HARM. ARCING/THERMAL DAMAGE WAS NOT OBSERVED. THERE WAS NO BROKEN/LOOSE CABLE. PHOTOGRAPHIC IMAGE OF THE DEVICE(S) WAS AVAILABLE FOR ISI REVIEW. INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY WERE REQUESTED HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507523 ENDOWRIST CURVED BIPOLAR DISSECTOR NAY INTUITIVE SURGICAL, INC 471344-16 N10210726 0058 00886874121511

    Patients

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