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

Model Number MESE1

Device Problem Self-Activation or Keying (1557)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 10/1/2020.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.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.

Event Description

It was reported that during a thyroid procedure, the device continuously ran and wouldn't turn off.It is unknown how case was completed or if there were any patient consequences.No additional information is available at this time.

Manufacturer Narrative

(b)(4).Date sent: 12/14/2020.Per service manual operational and diagnostic analysis did not confirm the reported continuous activation.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: 10612416
• MDR Text Key: 220949279
• Report Number: 1721194-2020-00051
• 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: 09/08/2020

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: 11/18/2020
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 11/18/2020
• Supplement Dates FDA Received: 12/14/2020
• Patient Sequence Number: 1