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

Catalog Number MESE1

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 4/4/2024.D4: batch # unk.B3: only event year known: 2024.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.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.

Event Description

It was reported that during an unknown procedure the smoke flue does not stop or the smoke flue switch does not turn on.There was no adverse consequence to the patient.

Manufacturer Narrative

(b)(4).Date sent: 5/16/2024.Investigation summary the reproducibility of the requested failure could not be confirmed.Foot control sensor cable was replaced as a preventive replacement.After replacement, a comprehensive inspection was performed to confirm that the cable was good.Comprehensive inspection details: pressure leak test, pump current consumption test, one-hour burn-in test, flow test, and interlocking test, 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.

Manufacturer Narrative

(b)(4).Date sent: 5/20/2024.For mwr-16052024-0001636398 report submission due date was 4/20/2024.It should have read 6/15/2024.G3 read 3/21/2024.G3 should have been 5/16/2024.For mwr-16052024-0001636398 report.Submission due date was 4/20/2024.It should have read 6/15/2024.G3 read 3/21/2024.G3 should have been 5/16/2024.

• 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 ; PR ; 3035526892
• MDR Report Key: 19042820
• MDR Text Key: 339390494
• Report Number: 1721194-2024-00038
• Device Sequence Number: 1
• Product Code: FYD
• UDI-Device Identifier: 10614559104545
• UDI-Public: 10614559104545
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2024

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 Catalogue Number: MESE1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 03/21/2024; 05/16/2024
• Supplement Dates FDA Received: 05/16/2024; 05/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1