BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 13697238 · Received March 8, 2022

    Report

    Report Number
    2955842-2022-10537
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    February 8, 2022
    Report Date
    February 9, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110195
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ENDOSCOPE AND COMPLETED ITS INVESTIGATION. FAILURE ANALYSIS (FA) RECEIVED THE SCOPE 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 AND/OR THIS EVENT. FURTHERMORE, VERIFICATION OF THE EVENT DETAILS CANNOT BE PERFORMED VIA SYSTEM LOGS DUE TO LACK OF EVENT INFORMATION. BASED ON THE ADDITIONAL INFORMATION OBTAINED FROM FAILURE ANALYSIS INVESTIGATIONS THIS IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: FAILURE ANALYSIS ACKNOWLEDGES THAT A FRAGMENT WAS 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

    THE ENDOSCOPE WAS RETURNED WITH NO REPORTED COMPLAINT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1325659 NONE ENDOSCOPE NAY INTUITIVE SURGICAL, INC 370891-05 N/A 00886874110195

    Patients

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