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

Model Number MESE1

Device Problem Difficult or Delayed Activation (2577)

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.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.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 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.

Manufacturer Narrative

(b)(4).Date sent: 9/17/2021.Investigation summary: per service manual operational and diagnostic analysis confirmed the activation issue and continuous activation issue.The pcb assembly was replaced as identified in the investigation to address the issues.The repair and testing of the unit was completed per the service manual, bringing the unit back to full functionality.The unit passed all functional tests and is fully operational.The batch history records were reviewed and certified by external manufacturing that the manufacturing criteria was met prior to the release of the equipment.The certificate records are accessible through external manufacturing.

Manufacturer Narrative

(b)(4).Date sent: 9/1/2021.Video analysis: this is a analysis for a video submitted to ethicon endo surgery for evaluation.Image: the video provide by the customer is that where a smoke evacuator can be observed.No conclusion could be reached as to how this issue occurred through video analysis.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.We value your assistance in providing us an opportunity to evaluate the reported event as all information reported to our company is critical to our continuous improvement efforts.Because the instrument was not returned our evaluation is limited.We value the opportunity to fully analyze the instrument upon its return.

• 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: 12317774
• MDR Text Key: 266377406
• Report Number: 1721194-2021-00061
• 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,foreig
• 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: 09/02/2021
• Initial Date Manufacturer Received: 07/27/2021
• Initial Date FDA Received: 08/13/2021
• Supplement Dates Manufacturer Received: 08/16/2021; 09/02/2021
• Supplement Dates FDA Received: 09/01/2021; 09/17/2021
• Patient Sequence Number: 1