BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 15843243 · Received November 22, 2022

    Report

    Report Number
    15843243
    Event Type
    Malfunction
    Date Received
    November 22, 2022
    Date of Event
    October 24, 2022
    Report Date
    November 8, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    UPON DOCKING THE DA VINCI SURGICAL SYSTEM, THE CAMERA WAS INSERTED INTO ARM #2 AND WAS GIVING AN ERROR CODE THAT THE CAMERA WAS NOT INSTALLED CORRECTLY. THE CAMERA WAS THEN TAKEN OUT AND RESEATED ON THE ARM #2 AND THE SAME ERROR CODE WAS GIVEN. THE DOCTOR THEN TOOK THE CAMERA AND DOCKED IT INTO ARM #3 AND NO ERROR CODE WAS GIVEN. THE DA VINCI SYSTEM WAS THEN UNDOCKED AND THE DRAPE WAS REMOVED CAREFULLY AND NEW DRAPE WAS APPLIED TO THE ARM. THE DA VINCI SURGICAL SYSTEM WAS THEN REDOCKED AND THE CAMERA WAS INSERTED INTO ARM #2 AND ERROR CODE WAS NO LONGER IN EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2781579 NONE SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC. 470015

    Patients

    Seq Age Sex Outcome Treatment
    1 24090 DA Unknown