BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12MM 0 DEGREE ENDOSCOPE

    MDR report key: 3982060 · Received August 5, 2014

    Report

    Report Number
    2955842-2014-04741
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 11, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K001666
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM ENDOSCOPE PROJECTS LIGHT FROM THE ILLUMINATOR ONTO THE SURGICAL SITE AND THE VIDEO IMAGE OF THE SURGICAL SITE CAPTURED BY THE ENDOSCOPE IS SENT BACK THROUGH LEFT AND RIGHT CHANNELS TO THE CAMERA HEAD. THE ENDOSCOPE WAS RETURNED TO THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR EVALUATION. THE OEM FOUND THAT THE DISTAL WINDOW IS MISSING, RESULTING IN FLUID INVASION SUBSEQUENT MAJOR DAMAGE TO THE OPTICAL COMPONENTS. THE REPROCESSING INSTRUCTIONS FOR CLEANING ENDOSCOPES SPECIFICALLY STATES: EXERCISE CARE WHEN CLEANING AND HANDLING THE DISTAL END OF THE ENDOSCOPE. DO NOT EXERT EXCESSIVE FORCE ON DISTAL WINDOWS AND NEVER CLEAN WITH SHARP OBJECTS OR INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE MISSING DISTAL WINDOW FOUND DURING FAILURE ANALYSIS INVESTIGATION, COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 12MM 0 DEGREE ENDOSCOPE WAS BLURRY. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT, AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456589 12MM 0 DEGREE ENDOSCOPE ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 311464-05

    Patients

    Seq Age Sex Outcome Treatment
    1