MAUDE Adverse Event Report: Megadyne Medical Products, Inc. MEGADYNE; Megadyne¿ Smoke Evacuator

Catalog Number	MESE1
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Ventilation Problem in Device Environment (3027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction

• Brand Name: MEGADYNE
• Common Device Name: 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: orla o'mahony ; 475 calle c; guaynabo ; PR ; +1(303)552-6892
• MDR Report Key: 50175117
• Report Number: 1721194-2026-00035
• Device Sequence Number: 18650826
• Product Code: FYD
• UDI-Device Identifier: 10614559104545
• UDI-Public: 10614559104545
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: MESE1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/13/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/21/2026
• Supplement Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown