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

Model Number MESE1

Device Problems Difficult or Delayed Activation (2577); Appropriate Term/Code Not Available (3191)

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

Event Date 07/27/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.A serial number was received and dhr 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: was rf sensor or the connect cable the issue? we have tried both the rf sensor & the connect cable.Was there manual activation? there was no need for manual activation.What was the set-up in the first two cases with no issue? there was no problem in the first two cases.If direct connect cable activated was the sensor setting adjusted on mese1? yes the sensor was adjusted to see if it would activate the auto shutoff & quiet the noise it did not.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 hip surgery during the third case of the smoke evacuator being used, on the auto activation it stayed on.The evacuator then began making a louder noise from the back of the fan.The case was completed with no patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 9/7/2021.

Manufacturer Narrative

(b)(4).Date sent: 9/16/2021.Investigation summary: per service manual operational and diagnostic analysis did not confirm that the auto activation stayed on.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: 12317858
• MDR Text Key: 266377940
• Report Number: 1721194-2021-00063
• 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,Followup
• Report Date: 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
• 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: 08/19/2021
• Initial Date Manufacturer Received: 07/27/2021
• Initial Date FDA Received: 08/13/2021
• Supplement Dates Manufacturer Received: 08/19/2021; 09/15/2021
• Supplement Dates FDA Received: 09/07/2021; 09/16/2021
• Patient Sequence Number: 1