BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLICKCLEAN

    MDR report key: 9149536 · Received October 3, 2019

    Report

    Report Number
    3012452802-2019-00001
    Event Type
    Malfunction
    Date Received
    October 3, 2019
    Date of Event
    July 23, 2019
    Report Date
    August 8, 2019
    Manufacturer
    MEDEON BIODESIGN, INC.
    Product Code
    GCJ
    UDI-DI
    04719872920182
    PMA / PMN Number
    K160172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE ALREADY SENT A PAPER MDR (FORM 3500A) TO THIS CASE AND RECEIVED A MAIL FROM FDA TO INFORM US THE NEED TO SUBMIT A REPORTING CASE VIA EMDR.ON AUG. 26, 2019. OUR REPORT WAS DELAYED DUE TO THE ENROLLMENT PROCESS. IT IS OUR FIRST ELECTRONIC REPORT . SIGNUP PROCESS NEEDED TO BE SET UP.

    Description of Event or Problem · 1

    IN ONE OF THE CLICKCLEAN CLINICAL USE, THE LOWER PART OF THE SCREEN IS BLOCKED AND MORE THAN 6 CLICKS CANNOT CLEAR THE VIEW: THE BLOCKAGE HAPPENED FROM THE BEGINNING OF THE CASE, NOT DURING THE CASE. THE BLOCKAGE LOOKED "CLOUDY" AND "BLURRY" AND USER CAN SEE THE OBJECTS VAGUELY, JUST AS SEE THROUGH FOG. AT THE BEGINNING OF THE 1ST CLICKCLEAN USE, THE BLURRY ACCOUNT FOR 25% OF THE LOWER-LEFT CORNER OF THE SCREEN. THE NURSE CLEANED THE SCOPE BY A SURGICAL SPONGE BEFORE INSERTING THE SCOPE TO 2ND CLICKCLEAN. THE BLOCKAGE ON THE 2ND CLICKCLEAN IS AROUND 10%-15% NEAR THE BOTTOM LEFT EDGE OF THE SCREEN. THE TOTAL PROCEDURE DELAY DUE TO CLICKCLEAN SWAP IS AROUND 3-5MIN. THE USER USED THE 2ND CLICKCLEAN TO THROUGHOUT THE REST OF THE SURGICAL PROCEDURE. THE TWO DEVICES WERE NOT ABLE TO BE RETURNED AND NOT ABLE TO VERIFY IF THE DEVICE OR SCOPE CAUSE THE IMAGE BLACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944869 CLICKCLEAN LAPAROSCOPE LENS SHIELD DEVICE GCJ MEDEON BIODESIGN, INC. UL330 18120601 04719872920182

    Patients

    Seq Age Sex Outcome Treatment
    1