BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED DUAL AXIS SWIVEL ADAPTER

    MDR report key: 19133995 · Received April 18, 2024

    Report

    Report Number
    1217052-2024-00009
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    March 1, 2024
    Report Date
    September 10, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    EHZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    B3. DATE OF EVENT: UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. D4. LOT NUMBER, EXPIRATION DATE, UDI, AND H4. MANUFACTURE DATE ARE UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. H3. REASON DEVICE NOT EVALUATED BY MFG: OTHER; DEVICE WAS NOT RETURNED TO MANUFACTURER. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RUBBER CAP HAD TO BE REMOVED TO INSERT THE SCOPE, CAUSING THE VOLUME OF AIR TO LEAK AND LOSING PEEP. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2237698 ANGLED DUAL AXIS SWIVEL ADAPTER EVACUATOR, ORAL CAVITY EHZ SMITHS MEDICAL ASD, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown