BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPE

    MDR report key: 20390072 · Received October 7, 2024

    Report

    Report Number
    2955842-2024-20202
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    September 12, 2024
    Report Date
    September 12, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    04250480109076
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE ENDOSCOPE FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    THE HANDHELD CAMERA WAS ANALYZED BY THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) AND THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS. THERE WERE NO ISSUES FOUND UPON INSPECTION OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE CUSTOMER SMELLED A BURNING SMELL AND NOTICED THAT THE HANDHELD CAMERA WAS IN A SEPARATE DRAPE AND HAD BURNT THROUGH THE DRAPE. THEY STATED THAT THE CAMERA AND THE LIGHTGUIDE WERE DETACHED BUT THE LIGHT GUIDE HAD A RED LIGHT COMING OUT OF IT. THE LIGHT WAS RED POSSIBLE BEING SHINED THROUGH A BLUE DRAPE. THE CUSTOMER STATED THEY TURNED OFF THE LIGHT SOURCE WHEN THEY GOT DONE USING IT PRIOR TO PUTTING IT IN A DRAPE. THE LIGHT SOURCE WAS ATTACHED TO THE SCOPE PORTION OF THE HANDHELD THE ENTIRE TIME. IT WAS STATED EITHER THEY BUMPED THE CAMERA BUTTON FOR TURNING ON THE LIGHT SOURCE OR THEY FORGOT TO TURN THE LIGHT SOURCE OFF WHEN THEY PUT IT IN THE DRAPE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE LIGHT GUIDE WAS PLACED INTO A POCKET ON THE DRAPE WHEN THE INCIDENT OCCURRED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2547620 ENDOSCOPE N/A NAY INTUITIVE SURGICAL, INC 470655-01 N/A 04250480109076

    Patients

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