BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 13695610 · Received March 8, 2022

    Report

    Report Number
    2955842-2022-10530
    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
    00886874110218
    PMA / PMN Number
    K101077
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ENDOSCOPE ASSOCIATED WITH THIS COMPLAINT AND COMPLETED ITS INVESTIGATION. FAILURE ANALYSIS (FA) RECEIVED THE SCOPE WITH MECHANICAL DAMAGE TO DISTAL ILLUMINATION FIBERS. FA ALSO NOTED 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 COMPLAINT 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. INTUITIVE SURGICAL, INC. (ISI) COMPLETED CUSTOMER FOLLOW UP AND OBTAINED THE FOLLOWING INFORMATION: THE CUSTOMER EXPLAINED HE COULD NOT PROVIDE FURTHER DETAILS REGARDING THE ISSUE WITH THE SCOPE. HOWEVER, IT WAS CONFIRMED THAT AS SOON AS THE ISSUE WAS IDENTIFIED THE SITE SWAPPED TO BACK-UP SCOPE AND COMPLETED THE PROCEDURE WITH NO REPORT OF PATIENT INJURY. THERE WAS NO INDICATION THAT FRAGMENTS BROKE OFF THE SCOPE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766864 NONE ENDOSCOPE, FIREFLY NAY INTUITIVE SURGICAL, INC 370893-04 N/A 00886874110218

    Patients

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