MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN BLADE MOD 2.5IN; E-Z CLEAN BLADE MODIFIED 2.5 INCH

Catalog Number	0012M
Medical Device Problem Code	Arcing of Electrodes (2289)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 10/20/2025.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.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.No lot or batch number was provided therefore a device history could not be done.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 or Problem Description
It was reported that during an unknown procedure that the bovie tip caused a small flame to form.Surgeon informed tech and circulator what occurred.Bovie tip was taken off the field and a new bovie tip was opened and used for the rest of the case.Coordinator was called to the room to be informed by surgeon what occurred.Coordinator took bovie tip out of the room for further investigation.Patient wasn't harmed from the fire that the bovie tip caused.It was on a megadyne generator (sn (b)(6)) and a megadyne bovie pencil.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/13/2025 h10: related report: (b)(4).Corrected data: b3.Investigation summary - the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the device was returned with the tip of the electrode melted and charring present.The most likely cause of this damage is caused by operating the electrosurgery equipment (generator) at high power settings with continual activation of the electrode for long periods or by placing the electrode tip against another instrument causing extreme heat which results in the melting of the tip.It is possible that this issue could have caused the event reported.As part of the quality process all devices are manufactured, inspected, and released to approved specifications.No lot or batch were provided, bhr could not be performed.

• Brand Name: E-Z CLEAN BLADE MOD 2.5IN
• Common Device Name: E-Z CLEAN BLADE MODIFIED 2.5 INCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek road; cincinnati OH 45242
• Manufacturer (Section G): ETHICON ENDO SURGERY INDEPENDENCIA; chihuahua ; MX
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 23336524
• Report Number: 1721194-2025-00073
• Device Sequence Number: 7819047
• Product Code: GEI
• UDI-Device Identifier: 10614559100110
• UDI-Public: 10614559100110
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K081791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

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: 0012M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male