BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMOKE EVACUATOR

    MDR report key: 11784826 · Received May 6, 2021

    Report

    Report Number
    1721194-2021-00040
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    January 1, 2021
    Report Date
    April 21, 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: 6/1/2021. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WHAT WAS PLUGGED INTO THE RF SENSOR? ZIP PEN, CODE 252510. HOW WAS THE PRODUCT SET UP? 252510 CONNECTED TO AN ERBE GENERATOR AND MEGADYNE SMOKE EVAC. WHY WAS THE RF SENSOR USED? TO DETECT THE ZIP PEN AND EXTRACT THE SMOKE. CONNECT CABLE WAS CONNECTED TO GEN11. WAS THE SENSITIVITY OF DEVICE ADJUSTED? NOT UNDERSTAND WHAT IS THIS. WAS THE GEN11 CONNECTED TO THE MSESE1 VIA THE DIRECT CONNECT CABLE? YES. WAS THERE ANY PATIENT CONSEQUENCES? NO. WAS THE PROCEDURE A LAPAROSCOPIC OR OPEN PROCEDURE? LAP/OPEN (HYBRID PROCEDURE). DID THIS OCCUR DURING THE SURGERY OR PRIOR TO THE SURGERY? DURING SURGERY.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 9/13/2021.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 9/15/2021. INVESTIGATION SUMMARY: PER SERVICE MANUAL OPERATIONAL AND DIAGNOSTIC ANALYSIS DID NOT CONFIRM THE REPORTED CONTINUOUS ACTIVATION. 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. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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 WAS PLUGGED INTO THE RF SENSOR? HOW WAS THE PRODUCT SET UP? WHY WAS THE RF SENSOR USED? WAS THE SENSITIVITY OF DEVICE ADJUSTED? WAS THE GEN11 CONNECTED TO THE MSESE1 VIA THE DIRECT CONNECT CABLE? WAS THERE ANY PATIENT CONSEQUENCES? WAS THE PROCEDURE A LAPAROSCOPIC OR OPEN PROCEDURE? DID THIS OCCUR DURING THE SURGERY OR PRIOR TO THE SURGERY? IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE A RF SENSOR CAUSED CONTINUOUS ACTIVATION; CONNECT CABLE DID NOT CAUSE ACTIVATION WHEN CONNECTED TO GEN11. THE UNIT CONTINUED TO BE ACTIVATED DESPITE PRESSING MANUAL TO TURN IT OFF. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679399 SMOKE EVACUATOR MEGADYNE¿ SMOKE EVACUATOR FYD MEGADYNE MEDICAL PRODUCTS, INC. MESE1 10614559104545

    Patients

    Seq Age Sex Outcome Treatment
    1