BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 24526248 · Received March 5, 2026

    Report

    Report Number
    2955842-2026-15196
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    February 12, 2026
    Report Date
    March 27, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    UDI-DI
    00886874115725
    PMA / PMN Number
    K191043
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE HANDHELD CAMERA FOR EVALUATION, BUT EVALUATION HAS NOT BEEN COMPLETED AS OF THE DATE OF THIS REPORT. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE HANDHELD CAMERA WAS ANALYZED AND FOUND TO FOUND TO HAVE A BROKEN LIGHT GUIDE ADAPTER. A VISUAL INSPECTION OF THE ADAPTER AND IC HOUSING FOR DAMAGE SUCH AS DEEP SCRATCHES, CRACKS, FOREIGN LABELING, FADED OR MISSING LABELING, AND MISSING PARTS WERE PERFORMED AND FAILED. THE IC HOUSING WAS INSPECTED AND THERE WAS ADDITIONAL DAMAGE TO FOUR OUT OF FOUR BROKEN LEGS. THE ADAPTER WAS RETURNED DAMAGED AND WITH MISSING SPRINGS AND COULD NOT BE REASSEMBLED TO THE IC HOUSING. THE HANDHELD CAMERA WAS EVALUATED AND DETERMINED TO BE UNABLE TO DO THE QUALITY ASSURANCE PROCEDURE AND COULD NOT CONFIRM LIGHT GUIDE ENGAGEMENT, FUNCTIONAL TESTING, VIDEO START UP OR INITIALIZATION. THE LIGHT GUIDE ADAPTER WAS INSPECTED AND THERE WAS A MISSING RETURN SPRINGS ALONG WITH THE ADAPTER DAMAGE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO DAMAGE DURING USE OR IMPROPER HANDLING, WHICH MAY INCLUDE PULLING FROM ONLY THE LIGHT GUIDE OR CAMERA CABLE WHEN UNPLUGGING THE ASSEMBLED CAMERA CONNECTOR FROM THE ENDOSCOPE CONTROLLER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HANDHELD CAMERA WAS OBSERVED TO HAVE A PIECE BROKEN OFF. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581152 NONE HANDHELD CAMERA HEAD GCJ INTUITIVE SURGICAL, INC 470035-03 N/A 00886874115725

    Patients

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