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

Model Number MESE1

Device Problems Difficult or Delayed Activation (2577); Noise, Audible (3273)

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

Event Date 01/31/2023

Event Type  malfunction  

Event Description

It was reported the during an unknown procedure there are strange "tik tak" sounds heard especially in lap mode (lv1-5).The smoke evacuator would activate automatically even though the energy capital/ diathermy has not activated and the smoke evacuator would not stop after run time has reached/ manual stop button is pressed.It is noisy when operating in open mode (lv3-5).

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.Video images were received and are pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4).Date sent: 3/7/2023.Video and photo analysis: this is an analysis of a set of videos and an image submitted for evaluation.Videos (vid-(b)(4), (b)(4), and (b)(4)): the videos provided by the customer show a mese1 being used in a procedure with no apparent damage.Image: the image provided by the customer shows mese1 label.The serial number could be seen as (b)(6).The event described could not be confirmed as no detectable damage could be observed.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be observed during the photo analysis.A manufacturing record evaluation was performed for the finished device batch number (b)(6), and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 4/5/2023.Investigation summary: per service manual operational and diagnostic analysis did not confirm the reported continuous activation or self activation.The noise issue was confirmed and the scroll pump was replaced as identified in the investigation to address the issue.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 repair and testing of the unit was completed.

• Brand Name: SMOKE EVACUATOR
• Type of Device: MEGADYNE¿ SMOKE EVACUATOR
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek road; cincinnati OH 45242
• Manufacturer (Section G): MEGADYNE MEDICAL PRODUCTS, INC.
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 16371862
• MDR Text Key: 309489956
• Report Number: 1721194-2023-00040
• Device Sequence Number: 1
• Product Code: FYD
• UDI-Device Identifier: 10614559104545
• UDI-Public: 10614559104545
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2023

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 02/14/2023
• Supplement Dates Manufacturer Received: 02/20/2023; 03/21/2023
• Supplement Dates FDA Received: 03/07/2023; 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1