BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO KIT

    MDR report key: 12737243 · Received November 2, 2021

    Report

    Report Number
    1423395-2021-00055
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Date of Event
    October 4, 2021
    Report Date
    November 2, 2021
    Manufacturer
    MEDLINE INDUSTRUIES LP
    Product Code
    NWR
    UDI-DI
    10193489375152
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE VALVES WERE INSERTED INTO THE SCOPE AS USUAL WITH NO DEVIATION FROM THE USUAL PROCEDURE. BEFORE THE PROCEDURES STARTED THE SCOPE WAS TESTED FOR FLUSHING AIR/CO2 INSUFFLATION. EVERYTHING WAS WORKING APPROPRIATELY UNTIL INSERTION OF THE SCOPE INTO THE PATIENT. AFTER INSERTION THE SCOPE WAS LEAKING/SPLATTERING WITH WATER VIA THE VALVES. THE CLINICIAN WAS NOT ABLE TO PUT AIR/CO2 INTO THE PATIENT TO SEE THE LUMEN. ACCORDING TO THE REPORTER THE SCOPE WAS WITHDRAWN, THE VALVES WERE CHANGED TO A DIFFERENT BRAND AND THE SCOPE WAS CHECKED AGAIN WITH NO DEFICIENCIES NOTED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VALVES WERE LEAKING AND THE CLINICIAN COULD NOT INSUFFLATE USING CO2 WHEN DOING A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1632521 ENDO KIT NWR MEDLINE INDUSTRUIES LP 20110402 10193489375152

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention