BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMOKE EVACUATOR

    MDR report key: 12041079 · Received June 22, 2021

    Report

    Report Number
    1721194-2021-00050
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    January 1, 2021
    Report Date
    June 10, 2021
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    FYD
    UDI-DI
    10614559104545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 6/28/2021. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WHAT DEVICE WAS IT ATTACHED TO? ATTACHED TO OUR 251010J SMOKE EVACUATION PENCIL. WAS THE DEVICE CONNECTED VIA DIRECT CONNECT OR RF SENOR? IT WAS DIRECTLY CONNECTED TO THE UNIT.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 8/12/2021. PER SERVICE MANUAL OPERATIONAL AND DIAGNOSTIC ANALYSIS DID NOT CONFIRM THAT THE UNIT CONTINUOUSLY RUNS. NO FURTHER INVESTIGATION WILL BE CONDUCTED ON THIS COMPLAINT. THE DEVICE HISTORY RECORDS WERE REVIEWED AND CERTED BY EXTERNAL MANUFACTURING THAT THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THE EQUIPMENT. THE CERTIFICATE RECORDS ARE ACCESSIBLE THROUGH EXTERNAL MANUFACTURING.

    Additional Manufacturer Narrative · 1

    (B)(4). ONLY EVENT YEAR KNOWN: 2021. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE WERE IDENTIFIED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: WHAT DEVICE WAS IT ATTACHED TO? WAS THE DEVICE CONNECTED VIA DIRECT CONNECT OR RF SENOR?.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE UNIT WILL CONTINUOUSLY RUN. DOES NOT SYNC ACTIVATE ACCORDINGLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938453 SMOKE EVACUATOR MEGADYNE¿ SMOKE EVACUATOR FYD MEGADYNE MEDICAL PRODUCTS, INC. MESE1 10614559104545

    Patients

    Seq Age Sex Outcome Treatment
    1