BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLICKCLEAN 30 DEG

    MDR report key: 8875104 · Received August 8, 2019

    Report

    Report Number
    1223422-2019-00021
    Event Type
    Malfunction
    Date Received
    August 8, 2019
    Date of Event
    July 23, 2019
    Report Date
    August 8, 2019
    Manufacturer
    MEDEON BIODESIGN, INC.
    Product Code
    GCJ
    UDI-DI
    04719872920182
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE THE DOCTOR ATTEMPTED TO USE THE CLICKCLEAN AND THE LOWER LEFT PART WAS BLOCKED. SHE TRIED TO CLEAR IT SEVERAL TIMES AND WAS UNSUCCESSFUL. THE ANESTHESIA TIME WAS EXTENDED BRIEFLY. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670095 CLICKCLEAN 30 DEG LAPAROSCOPE LENS SHIELD DEVICE GCJ MEDEON BIODESIGN, INC. UL330 UNKNOWN 04719872920182

    Patients

    Seq Age Sex Outcome Treatment
    1