BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20177955 · Received September 10, 2024

    Report

    Report Number
    2955842-2024-19265
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Date of Event
    August 21, 2024
    Report Date
    August 21, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112342
    PMA / PMN Number
    K150284
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED FOR TROUBLESHOOTING ASSISTANCE. THE CUSTOMER WAS ABLE TO REMOVE THE MEGA NEEDLE DRIVER INSTRUMENT WITH THE CANNULA STILL ATTACHED. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT INVOLVED IN THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT ISSUE THE RETURN OF THE INSTRUMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DIAPHRAGMATIC PLICATION SURGICAL PROCEDURE, THE MEGA NEEDLE DRIVER INSTRUMENT WAS STUCK ON THE UNIVERSAL SURGICAL MANIPULATOR (USM). THE CUSTOMER WAS ABLE TO EVENTUALLY REMOVE IT WITH THE CANNULA STILL ATTACHED AND IT WAS NOTED THAT IN THE WRIST/JAW AREA THERE WAS A DAMAGED CABLE STICKING OUT. THE CUSTOMER REPLACED THE INSTRUMENT AND THE CANNULA WITH A SPARE TO RESOLVE THE REPORTED PROBLEM AND THEY WERE CONTINUING AS PLANNED. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2330063 ENDOWRIST MEGA NEEDLE DRIVER NAY INTUITIVE SURGICAL, INC 470194-08 K10240125 0097 00886874112342

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES