BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 19601962 · Received June 24, 2024

    Report

    Report Number
    2955842-2024-16148
    Event Type
    Malfunction
    Date Received
    June 24, 2024
    Date of Event
    May 29, 2024
    Report Date
    May 30, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K150837
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE RESULTED IN NON-INTUITIVE MOTION OF THE INSTRUMENT: THE INSTRUMENT MOVED AUTOMATICALLY WITH NO COMMAND. THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM. THE ISSUE WAS RESOLVED BY REATTACHING THE STERILE ADAPTER (SA). THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH THE SAME DA VINCI SYSTEM CONFIGURATION. THE PROCEDURE WAS NOT CONVERTED. THERE WAS NO PATIENT INJURY.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE ISI TECHNICAL SUPPORT ENGINEER (TSE) FOUND ERROR 22020 MULTIPLE TIMES IN THE LOGS AND EXPLAINED THAT AN ENGAGEMENT ISSUE BETWEEN THE USM 3, THE STERILE ADAPTOR (SA), AND THE INSTRUMENT MIGHT HAVE OCCURRED AT THAT TIME. THE TSE ADVISED THE CUSTOMER TO RESEAT THE SA AND THE INSTRUMENT. NO SITE VISIT WAS CONDUCTED. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE PRODUCT WAS NOT RETURNED, THE INFORMATION GATHERED 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 SURGICAL PROCEDURE, THE TIP OF THE SMALL CLIP APPLIER INSTRUMENT ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) 3 MOVED UNINTENTIONALLY. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOUND ERROR 22020 MULTIPLE TIMES IN THE LOGS AND EXPLAINED THAT AN ENGAGEMENT ISSUE BETWEEN THE USM 3, THE STERILE ADAPTER (SA), AND THE INSTRUMENT MIGHT HAVE OCCURRED AT THAT TIME. THE TSE ADVISED THE CUSTOMER TO RESEAT THE SA AND THE INSTRUMENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280845 ENDOWRIST CLIP APPLIER, SMALL, HORIZON NAY INTUITIVE SURGICAL, INC 470401-07 N/A

    Patients

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