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

Model Number MESE1

Device Problems Difficult or Delayed Activation (2577); Ventilation Problem in Device Environment (3027)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Unknown; captured as awareness date.Additional information: the evacuators do power on.Essentially, at sensitivity 3, the 3 evacuators will not automatically kick on to evacuate smoke with connect cable connected when the monopolar pencil power level is below 100, they are connected to ft10¿s.At sensitivity level 4, the evacuators turn on and begin evacuating smoke without stopping.They will not stop evacuating once turned on, until entire unit is turned off.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during an unknown procedure, the smoke evacuator will not energize when the ft10 generator is powered on.(b)(4).

Manufacturer Narrative

(b)(4).Date sent: 3/18/2021.Per the service manual, the operational and diagnostic analysis did not confirm that the evacuator will not energize when the ft10 generator is powered on or the continuous evacuation of smoke.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.

• Brand Name: SMOKE EVACUATOR
• Type of Device: MEGADYNE¿ SMOKE EVACUATOR
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 11358511
• MDR Text Key: 233050136
• Report Number: 1721194-2021-00015
• Device Sequence Number: 1
• Product Code: FYD
• UDI-Device Identifier: 10614559104545
• UDI-Public: 10614559104545
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

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
• Device Operator: Health Professional
• Device Model Number: MESE1
• Device Catalogue Number: MESE1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/22/2021
• Supplement Dates Manufacturer Received: 02/23/2021
• Supplement Dates FDA Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1