BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 20516861 · Received October 23, 2024

    Report

    Report Number
    2955842-2024-20836
    Event Type
    Malfunction
    Date Received
    October 23, 2024
    Date of Event
    September 27, 2024
    Report Date
    September 27, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112212
    PMA / PMN Number
    K171426
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE CHECKED THE ENDOSCOPE 30 DEG AND CONFIRMED THE ISSUE. ONE SIDE OF THE IMAGE WAS FLIPPED. WHEN FSE ROTATED THE BASE, THE ISSUE HAD DISAPPEARED. HOWEVER, ROTATED THE BASE FEW TIMES, THE ISSUE OCCURRED AGAIN. FSE REPLACED THE ENDOSCOPE. AFTER REPLACEMENT, CONFIRMED THAT NEW ENDOSCOPE WORKED PROPERLY. AFTER WORKING ON THIS ISSUE, THE SYSTEM WAS TESTED AND VERIFIED. THE SYSTEM IS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE 30-DEGREE 8MM ENDOSCOPE WAS ANALYZED AND TESTED AND PLACED ON IN-HOUSE SYSTEM OR EQUIVALENT FOR FUNCTIONAL TESTING AND FAILED TO PROVIDE A VIDEO DUE TO AN ELECTRICAL COMMUNICATION FAILURE. THE ENDOSCOPE WAS PLUGGED ON IN-HOUSE SYSTEM OR EQUIVALENT AND PROVIDED COLOR BARS IN BOTH EYES. THE ENDOSCOPE WAS VISUALLY INSPECTED AND/OR PLACED ON IN-HOUSE SYSTEM AND DETECTED WITH A CAMERA MODULE ISSUE. THE ENDOSCOPE WAS DISASSEMBLED, AND CAMERA MODULE WAS VISUALLY INSPECTED FOR DAMAGE AND/OR PLACED ON A DIAGNOSTIC TESTER. THE CAMERA MODULE EXHIBITED SENSOR BOARD CRACKED. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE 30-DEGREE ENDOSCOPE IMAGE WAS FLIPPED, AND ONLY ONE EYE WAS DISPLAYED. THE CUSTOMER REPLACED THE ENDOSCOPE TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE VISION ISSUE DID NOT RESULT IN PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2571991 NONE ENDOSCOPE NAY INTUITIVE SURGICAL, INC 470027-64 N/A 00886874112212

    Patients

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