BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 23961035 · Received January 5, 2026

    Report

    Report Number
    2955842-2025-49850
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Date of Event
    December 8, 2025
    Report Date
    February 12, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874116555
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE ENDOSCOPE; HOWEVER, FAILURE ANALYSIS IS STILL ONGOING. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE 30-DEGREE ENDOSCOPE PLUS FOR FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE AN ATTACHED ENDOSCOPE ADAPTER (AEA) BEARING FRICTION ISSUE USING A SCREENING AID TO MANUALLY ROTATE THE ADAPTER TO DETECT FOR FRICTION. THE CAMERA INSTRUMENT ADAPTER DID NOT ROTATE PROPERLY AND/OR NOISES WERE HEARD DURING TESTING AND CONFIRMED AS BINDING. ADDITIONAL OBSERVATIONS NOT REPORTED BY SITE: THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH DAMAGE TO THE BUTTON PACK ASSEMBLY. VISUAL INSPECTION CONFIRMED HAIRLINE CRACK ON ENTER CAMERA BUTTON EXHIBITING DAMAGE OF THE BUTTON PACK ASSEMBLY. THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH COSMETIC DAMAGE. DURING INSPECTION OF THE ENDOSCOPE CABLE INTEGRATED CONNECTOR, THE CABLE INTEGRATED CONNECTOR HOUSING EXHIBITED DISCOLORATION. VISUAL INSPECTION CONFIRMED. THE ENDOSCOPE WAS TESTED AND PLACED ON A CAMERA ATTENUATION TESTER OR EQUIVALENT TO MEASURE TRANSMITTANCE BUT FAILED FUNCTIONAL TESTING. THE ENDOSCOPE FAILED TRANSMITTANCE DUE TO THE MEASURED OUTPUT POWER NOT MEETING SPECIFICATION LIMITS. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INCISIONAL HERNIA TAPP SURGICAL PROCEDURE, THE CUSTOMER STARTED HAVING ISSUES WITH THE 30-DEGREE ENDOSCOPE PLUS CALIBRATION WHERE IT WOULD NOT ORIENT WITH THE HAND PIECES. THE IMAGE WAS OFF BY 180 DEGREES AND WAS RESOLVED BY POWER CYCLING THE SYSTEM. THE SITE WAS ADVISED TO CANCEL THE GUIDED TOOL CHANGE FUNCTION ON THE ENDOSCOPE ARM WITHOUT POWER CYCLING THE SYSTEM. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL TERRITORY ASSOCIATE AND OBTAINED THE FOLLOWING INFORMATION: THE SURGEON WAS IN THE PROCESS OF LYSIS OF ADHESIONS IN THE HERNIA SURGERY. THE IMAGE WAS ROTATED 90 DEGREES ONTO ITS SIDE HOWEVER THE BASE SHOWED THAT THE HORIZON SHOULD HAVE BEEN 30 DEGREES DOWN. THE ENDOSCOPE DID NOT MOVE WITH UNCONTROLLED MOTION NOR DID THE EVENT REVERSE CONTROL ON SYSTEM ARMS. THE IMAGE BEING DISPLAYED WAS OFF, SO THAT THE SURGEON WAS HAVING A DIFFICULT TIME HAVING HIS INSTRUMENTS IN THE CORRECT PLACE. THE ENDOSCOPE WAS INSTALLED 30 DEGREES DOWN AND THE SURGEON CONFIRMED THE DESIRED ORIENTATION WHEN THE ENDOSCOPE WAS INSTALLED. THE ENDOSCOPE¿S ADAPTER/BASE WAS STILL ENGAGED/IN-SYNCH/ATTACHED. THERE WAS NO DAMAGE OBSERVED ON THE ENDOSCOPE¿S ADAPTER/BASE. THE SURGEON MADE SURE THAT THE CAMERA WAS IN 30 DOWN WITH THE BUNNY EARS POINTED TO THE CEILING. THE ISSUE DID NOT CAUSE ANY INJURY TO THE PATIENT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268045 NONE ENDOSCOPE PLUS NAY INTUITIVE SURGICAL, INC 470057-08 N/A 00886874116555

    Patients

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