BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 23103145 · Received September 19, 2025

    Report

    Report Number
    2955842-2025-36478
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    August 14, 2025
    Report Date
    August 28, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE 0-DEGREE ENDOSCOPE PLUS FOR FAILURE ANALYSIS INVESTIGATION. THE ENDOSCOPE WAS ANALYZED AND FOUND WITH DAMAGE AT THE DISTAL END. THE DISTAL WINDOW LOCATED AT DISTAL TIP WAS VISUALLY INSPECTED AND FOUND CRACKED. 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 VISUALLY INSPECTED AND FOUND WITH MINOR CUT TO THE CABLE INSULATION. THE DAMAGE WAS LOCATED AT ZONE A NEAR INTEGRATED CONNECTOR OF THE ENDOSCOPE CABLE. THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH DAMAGE TO THE BUTT PACK ASSEMBLY. VISUAL INSPECTION CONFIRMED HAIRLINE CRACK ON ENTER BUTTON EXHIBITING DAMAGE OF THE LED BUTTON PACK ASSEMBLY. THE ENDOSCOPE WAS EVALUATED AND FOUND WITH A CAMERA INSTRUMENT ADAPTER DEFECT. THE ENDOSCOPE WAS PLACED THROUGH FRICTION TEST USING A SCREENING AIDE 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. THE CAMERA INSTRUMENT ADAPTER REMOVED FROM ENDOSCOPE HOUSING AND EVALUATED AND FOUND WITH ADVANCED ENDOSCOPE ADAPTER SHAFT BEARING CONTRIBUTING TO FRICTION. THE PROBABLE ROOT CAUSE OF THE CRACKED DISTAL WINDOW AND DETACHED FRAGMENT IS ATTRIBUTED TO ISSUES DURING USE, SUCH AS ACCIDENTAL IMPACT WITH HARD SURFACES, DROPPING OF THE SCOPE, OR IMPROPER CLEANING DURING REPROCESSING.

    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.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 0-DEGREE ENDOSCOPE PLUS HAD AN ISSUE WITH THE IMAGE. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE IMAGE WAS NOT INVERTED. THE ISSUE DID NOT INVOLVE A REVERSED CONTROL ON SYSTEM ARMS. THE ENDOSCOPE MOVED FREELY WITH UNCONTROLLED MOTION. THE IMAGE WAS BLURRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2843446 NONE ENDOSCOPE NAY INTUITIVE SURGICAL, INC 470056-08 N/A

    Patients

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