MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGADYNE; E-Z CLEAN BLADE MODIFIED 2.75 INCH

Catalog Number	0012AM
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 4/6/2026.D4 batch #: unknown.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.H10: mw5184124.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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 a tonsillectomy procedure, the cautery was not activating and misfiring.At start of case all connections checked by circulator, scrub nurse and surgeon told to check cautery tip connection surgeon removed and reinserted the tip as a response to this.Patient underwent surgery and once davis-boyle gag was released, surgeon identified significant partial to full thickness burns to the corners of the patient's mouth bilateral that had been caused during surgery.Surgeon immediately applied saline-soaked gauze to the area.Plastic surgery was made aware and staff brought into room to examine the area and will follow patient.Plastics came to the room, completed an assessment, took photographs, and recommended admission of the patient.Site cleansed with sterile ns, dried, and polypore ointment applied to areas by ear, nose, and throat surgeon.

• Brand Name: MEGADYNE
• Common Device Name: E-Z CLEAN BLADE MODIFIED 2.75 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: 24793004
• Report Number: 1721194-2026-00018
• Device Sequence Number: 21033989
• Product Code: GEI
• UDI-Device Identifier: 10614559100103
• UDI-Public: 10614559100103
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0012AM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown