MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. 10FT SMOKE PENCIL UCONN; RETURN ELECTRODE CABLE, DUAL PLATE

Model Number	251010J
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.The lot/batch/serial number was not provided; therefore, a manufacturing record evaluation could not be performed.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.
Event or Problem Description
It was reported that during an unknown procedure that the unit will continuously run.Does not sync activate accordingly.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/6/2021.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event, and is being considered not reportable.

• Brand Name: 10FT SMOKE PENCIL UCONN
• Common Device Name: RETURN ELECTRODE CABLE, DUAL PLATE
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 12074535
• Report Number: 1721194-2021-00054
• Device Sequence Number: 3926046
• Product Code: GEI
• UDI-Device Identifier: 10614559105573
• UDI-Public: 10614559105573
• Combination Product (Y/N): N
• PMA/510(K) Number: K982130
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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: 251010J
• Device Catalogue Number: 251010J
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 07/06/2021
• Patient Sequence Number: 1