BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 22672158 · Received July 30, 2025

    Report

    Report Number
    2955842-2025-32227
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    July 16, 2025
    Report Date
    July 16, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    UDI-DI
    00886874116555
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE 30-DEGREE ENDOSCOPE PLUS FOR FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT WAS ANALYZED AND WAS SUBJECTED TO A FRICTION TEST USING A SCREENING AID TO MANUALLY ROTATE THE CAMERA INSTRUMENT ADAPTER. THE ADAPTER DID NOT ROTATE PROPERLY, AND BINDING NOISES WERE OBSERVED, CONFIRMING FRICTION. ADDITIONAL OBSERVATIONS NOT REPORTED BY SITE: VISUAL INSPECTION REVEALED DAMAGE TO THE BUTTON PACK ASSEMBLY, INCLUDING A HAIRLINE CRACK ON THE LEFT/RIGHT SIDE OF THE ASSEMBLY. THE ENDOSCOPE WAS CONFIRMED TO HAVE A DEFECT IN THE CAMERA INSTRUMENT ADAPTER. FURTHER EVALUATION AFTER REMOVAL FROM THE HOUSING IDENTIFIED AN AEA SHAFT BEARING DEFECT CONTRIBUTING TO THE FRICTION. COSMETIC DAMAGE WAS OBSERVED. THE CABLE-INTEGRATED CONNECTOR HOUSING SHOWED DISCOLORATION, AND FURTHER INSPECTION REVEALED CORROSION ON THE SPRING FINGERS. A DIAGNOSTIC TEST, INCLUDING A LIGHT LEAKAGE TEST (OR EQUIVALENT), WAS PERFORMED TO ASSESS IMAGE QUALITY. AN ARTIFACT WAS DETECTED IN THE RIGHT EYE. FA PLUS: THE ENDOSCOPE WAS DISASSEMBLED, AND THE CAMERA MODULE WAS VISUALLY INSPECTED AND TESTED ON AN INTERNAL TESTER. THE CAMERA MODULE FAILED THE LIGHT LEAKAGE TEST. THE PROBABLE ROOT CAUSE OF THIS BINDING IS ATTRIBUTED TO COMPONENT SUSCEPTIBILITY TO INCREASED FRICTION. THIS ISSUE CAN BE RESOLVED BY USING AN ALTERNATE ENDOSCOPE TO COMPLETE THE PROCEDURE.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) THAT THE ENDOSCOPE STOPPED ROTATING. THE FSE ADVISED THE CUSTOMER TO SWITCH TO ANOTHER ENDOSCOPE IF NEEDED. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED IN THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT ISSUED THE RETURN OF THE 30-DEGREE ENDOSCOPE PLUS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE CUSTOMER INFORMED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT THE 30-DEGREE ENDOSCOPE WOULD FLIP AUTOMATICALLY AND MOVE NON-INTUITIVELY. THE CUSTOMER CONFIRMED THAT THERE WAS NO UNIVERSAL SURGICAL MANIPULATOR (USM) ARMS COLLISION AND NO ERRORS. TSE REVIEWED THE LOGS BUT COULD NOT FIND ANY RELATED ERRORS. THE CUSTOMER STATED THAT THE ISSUE DID NOT OCCUR AFTER CLEANING OR REMOVING THE ENDOSCOPE. THE TSE ADVISED THE CUSTOMER TO CLEAR GUIDE TOOL CHANGE (GTC) AND THEN RESEAT THE ENDOSCOPE TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ENDOSCOPE MOVED AUTOMATICALLY WITH NO COMMAND. IT WOULD NOT FLIP WHEN THE SURGEON USED THE CONTROLS TO FLIP IT; HOWEVER, IT WOULD FLIP WHEN THE SURGEON CHANGED THE HORIZON. THERE WERE NO PATIENT INJURIES AS RESULT OF THE EVENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT ENDOSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496704 NONE ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-08 N/A 00886874116555

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES