BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI

    MDR report key: 13587939 · Received February 23, 2022

    Report

    Report Number
    2955842-2022-10338
    Event Type
    Malfunction
    Date Received
    February 23, 2022
    Date of Event
    February 12, 2021
    Report Date
    January 27, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110201
    PMA / PMN Number
    K101077
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ENDOSCOPE INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) CONFIRMED THE CUSTOMER REPORTED COMPLAINT "FOGGING ISSUE". THE ENDOSCOPE WAS RECEIVED WITH MECHANICAL DAMAGE TO DISTAL WINDOW ASSEMBLY HERMETIC SEAL RESULTING IN FLUID INVASION AND SUBSEQUENT MAJOR DAMAGE TO OPTICAL COMPONENTS. FRAGMENTS OF THE EPOXY ARE POSSIBLY MISSING. ENDOSCOPE RECEIVED WITH MECHANICAL DAMAGE TO DISTAL ILLUMINATION FIBERS. FRAGMENTS OF THE FIBER OPTIC ARE MISSING. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT. NO IMAGE OR VIDEO WAS PROVIDED FOR REVIEW. VERIFICATION OF THE SI ENDOSCOPE PRODUCT VIA SYSTEM LOGS CANNOT BE PERFORMED BECAUSE SI ENDOSCOPE PRODUCT DETAILS ARE NOT CAPTURED IN THE SYSTEM LOG. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: FAILURE ANALYSIS ACKNOWLEDGES THAT FRAGMENTS WERE MISSING FROM A PORTION OF THE DEVICE THAT ENTERS THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE WAS NO REPORT FROM THE CUSTOMER THAT A FRAGMENT FROM THE INSTRUMENT FELL INTO THE PATIENT DURING THE PROCEDURE. WHILE THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT AND NO REPORT OF FRAGMENTS FALLING INTO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FRAGMENT(S) DID FALL INTO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ENDOSCOPE HAD FOGGING ISSUE. THE PROCEDURE WAS COMPLETED WITH A BACK-UP ENDOSCOPE WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65928 DA VINCI ENDOSCOPE NAY INTUITIVE SURGICAL, INC 370892-03 N/A 00886874110201

    Patients

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