BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20578707 · Received October 31, 2024

    Report

    Report Number
    2955842-2024-21388
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Date of Event
    October 7, 2024
    Report Date
    October 7, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112465
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) ADDRESSED THE REPORTED EVENT WITH PHONE SUPPORT. THE ISSUE WAS RESOLVED BY TECHNICAL SUPPORT ENGINEER (TSE) ADVISING TO REINSTALL THE STERILE ADAPTER (SA) AND INSTRUMENT. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. 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

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRECTOMY SURGICAL PROCEDURE, THE SURGEON WAS UNABLE TO APPLY THE CLIP USING THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT. THE SURGEON DID NOT IMPLEMENT THE REATTACHMENT OF THE INSTRUMENT AND THE STERILE ADAPTER (SA). INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ADVISED THAT IF SAME ISSUE OCCURRED, REINSTALL THE SA AND THE INSTRUMENT FIRST. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2067116 ENDOWRIST MEDIUM-LARGE CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470327-12 K11231027 0406 00886874112465

    Patients

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