BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 17463258 · Received August 4, 2023

    Report

    Report Number
    2955842-2023-17518
    Event Type
    Malfunction
    Date Received
    August 4, 2023
    Date of Event
    March 31, 2023
    Report Date
    July 6, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112205
    PMA / PMN Number
    K171426
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING 3D IMAGE ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE 0 DEGREE ENDOSCOPE WAS ANALYZED AND FOUND TO HAVE MECHANICAL DAMAGE TO THE SCOPE'S DISTAL TIP. THE ENDOSCOPE WAS TESTED AND PLACED ON AN IN-HOUSE SYSTEM OR EQUIVALENT FOR FUNCTIONAL TESTING AND FAILED TO PROVIDE A VIDEO DUE TO AN ELECTRICAL OR COMMUNICATION FAILURE. THE ENDOSCOPE WAS PLUGGED ON IN-HOUSE SYSTEM OR EQUIVALENT AND PROVIDED COLOR BARS IN THE LEFT EYE. ADDITIONAL OBSERVATION FOUND THAT THE ENDOSCOPE FAILED FUNCTIONAL TESTING DUE TO AN ELECTRICAL FAILURE. THE COMPLAINT REGARDING 3D IMAGE ISSUE WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO FRAGMENT THAT FELL INSIDE THE PATIENT'S ANATOMY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ENDOSCOPE 3D VIEWER LOST VIDEO. THE ENDOSCOPE WAS NOT WORKING. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1659930 NONE ENDOSCOPE NAY INTUITIVE SURGICAL, INC 470026-64 N/A 00886874112205

    Patients

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