BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20609272 · Received November 5, 2024

    Report

    Report Number
    20609272
    Event Type
    Malfunction
    Date Received
    November 5, 2024
    Date of Event
    July 25, 2024
    Report Date
    August 19, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    SELF TEST FAILED CLAIMS BLADE WAS ALREADY EXPOSED UPON FIRST INSERTION. NO PATIENT HARM. NO PATIENT CONTACT. ***** HAS BEEN REPORTED & RETURNED TO INTUITIVE SURGICAL RGA. ====================== MANUFACTURER RESPONSE FOR VESSEL SEALER, (BRAND NOT PROVIDED) (PER SITE REPORTER) ====================== ISSUED RGA AND WILL ISSUE CREDIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57231 ENDOWRIST SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC. 480422

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male