BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 18604035 · Received January 30, 2024

    Report

    Report Number
    2955842-2024-10836
    Event Type
    Malfunction
    Date Received
    January 30, 2024
    Date of Event
    November 24, 2023
    Report Date
    January 4, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112328
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PERMANENT CAUTERY SPATULA (PCS) INSTRUMENT INVOLVED WITH THIS COMPLAINT CONTAINS THE IMPROVED PITCH CABLE CRIMP RETENTION DESIGN WHICH MITIGATES THE POTENTIAL FOR A FRAGMENT FALLING INTO THE PATIENT. THE IMPROVED DESIGN CONTAINS REDESIGNED PULLEYS, PROXIMAL CLEVIS, AND CABLE DESIGN TO MINIMIZE THE POSSIBILITY FOR CABLE DERAILMENT AS WELL AS CABLE SEPARATION FROM THE CRIMP.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PCS INSTRUMENT FAILURE ANALYSIS. INVESTIGATION FOUND A BROKEN PITCH CABLE. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS NOT INSTALLED IN THE CLEVIS. WHEN PITCH CABLE BREAKAGE OCCURS, THE INSTRUMENT IS IMMEDIATELY INOPERABLE DUE TO LOSS OF FUNCTIONALITY. THE INSTRUMENT HAS TUNGSTEN DRIVE CABLES TO TRANSMIT MOTION FROM THE INPUT DISCS IN THE HOUSING, THROUGH THE MAIN SHAFT, AND TO THE DISTAL INSTRUMENT TIP. THESE CABLES ARE EXPOSED AT THE INSTRUMENT TIP AND CONTROL MOVEMENTS AT THE WRIST. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE PERMANENT CAUTERY SPATULA (PCS) INSTRUMENT CABLE WAS BROKEN. INTUITIVE SURGICAL, INC (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE CUSTOMER CONFIRMED NO FRAGMENT FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. THE HAS NOT PATIENT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETENTION OF FOREIGN MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2538297 ENDOWRIST PERMANENT CAUTERY SPATULA NAY INTUITIVE SURGICAL, INC 470184-14 K10230511 0056 00886874112328

    Patients

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