MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. SMOKE EVACUATOR RF SENSOR; MEGADYNE¿ RF SENSOR

Model Number	2255J
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 and no non-conformances were identified.A video was received and is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Additional information was requested, and the following was obtained: for scenario 1, was a different rf sensor tried? was the filter fully seated/connected? [ans: yes, different rf sensor has been tried and filter is connected.] for scenario 3, was a different rd sensor tried or was this the same rf sensor from scenario 1? [ans: yes, different rf sensor has been tried].If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during an unknown procedure, the account turned on the mese1 with rf sensor connected, and the smoke evacuation cannot be activated (even with connecting cable connected or manual button pressed).Then they turned on the mese1 with rf sensor disconnected, the smoke evacuation can be activated with manual button or connecting cable.Finally they turned on the mese1 without connecting rf sensor, once plugged in rf sensor, evacuation activate continuously without connecting diathermy or pressing manual button.After reboot, became the first issue.The above issues are testing without connecting to any diathermy or energy device.There were no patient consequences.

• Brand Name: SMOKE EVACUATOR RF SENSOR
• Common Device Name: MEGADYNE¿ RF SENSOR
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 12317800
• Report Number: 1721194-2021-00062
• Device Sequence Number: 2806516
• Product Code: FYD
• UDI-Device Identifier: 10614559104644
• UDI-Public: 10614559104644
• Combination Product (Y/N): N
• PMA/510(K) Number: K200250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2255J
• Device Catalogue Number: 2255J
• Device Lot Number: 002049
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/13/2021
• Patient Sequence Number: 1