BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 13614833 · Received February 26, 2022

    Report

    Report Number
    2955842-2022-10377
    Event Type
    Malfunction
    Date Received
    February 26, 2022
    Date of Event
    December 7, 2021
    Report Date
    January 31, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    UDI-DI
    00886874110218
    PMA / PMN Number
    K101077
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE 12MM 30-DEGREE ENDOSCOPE INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT OF "FOG INSIDE OF THE ENDOSCOPE." THE ENDOSCOPE WAS RECEIVED WITH MECHANICAL DAMAGE TO THE DISTAL WINDOW ASSEMBLY HERMETIC SEAL RESULTING IN FLUID INVASION AND SUBSEQUENT MAJOR DAMAGE TO THE OPTICAL COMPONENTS. FRAGMENTS OF THE EPOXY ARE POSSIBLY MISSING. THE ENDOSCOPE RECEIVED WITH MECHANICAL DAMAGE TO DISTAL ILLUMINATION FIBER. THE ENDOSCOPE HAD MECHANICAL DAMAGE AND OR DEEP SCRATCHES TO THE OCULAR SLEEVE AND SHAFT ASSEMBLY. FRAGMENTS OF THE FIBER OPTIC ARE MISSING. SI ENDOSCOPE PRODUCT INFORMATION WAS NOT AVAILABLE THROUGH THE SYSTEM LOGS. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS IDENTIFIED THROUGH FAILURE ANALYSIS TESTING THAT A FRAGMENT WAS MISSING FROM A PORTION OF THE DEVICE THAT ENTERS THE PATIENT (DISTAL END). 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, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 30 DEGREE ENDOSCOPE WAS FOUND TO HAVE FOGGING ISSUE. 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 ISSUE WAS IDENTIFIED PRIOR TO STARTING PROCEDURE, SO THE PATIENT WAS NOT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567686 NONE ENDOSCOPE, FIREFLY GCJ INTUITIVE SURGICAL, INC 370893-04 N/A 00886874110218

    Patients

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