BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI LARGE CLIP APPLIER

    MDR report key: 15659122 · Received October 21, 2022

    Report

    Report Number
    MW5112801
    Event Type
    Malfunction
    Date Received
    October 21, 2022
    Date of Event
    September 26, 2022
    Report Date
    October 19, 2022
    Manufacturer
    INTUITIVE SURGICAL G.K.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE USING THE DAVINCI AND THE INSTRUMENT (LARGE CLIP APPLIER) BROKE WHILE INSIDE THE PATIENT. ALL PIECES WERE ACCOUNTED FOR AND THE DEVICE WAS REMOVED FROM FIELD WITHOUT FURTHER INCIDENT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2744154 DAVINCI LARGE CLIP APPLIER SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL G.K. N10201123-0240

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female