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

Catalog Number	0012AM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 12/22/2025.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: (b)(4).Additional information was requested and the following was obtained: what medical intervention was used to treat the burn? (such as salve or stitches) the affected area had to be excised and closed in layers (stitches) besides the burn, did the patient experience any adverse consequence due to the issue? additional wound outside of surgical wound.Are there any anticipated long-term effects from the burn or injury? no what ethnicity is the patient? caucasian.What is the current status of the affected (patient or user)? stable index procedure: removal of a mediport catheter.Degree or type of burn: damage through the subcutaneous tissue.Care: excised and closed in layers (subcutaneous and skin).Photo: no.Detailed description of the medical intervention and post op treatment: of note, upon completion of this procedure, i noted there was a cautery burn medial to the right breast nipple-areolar complex, and i have no clear idea why this occurred.I never had a cautery laid down on the patient's chest as far as i could recollect and never heard any cautery sound indicator being activated.This area of the cautery burn was excised and closed in layers with 3-0 monocryl for the subcutaneous tissue followed by a running subcuticular 4-0 monocryl for the skin, and dermabond was applied.The patient's husband was notified by me personally at the end of the case and i will discuss this with the patient upon her waking up in the next 24 hours.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 when the surgeon entered to assist with device related concern during an unknown surgery where it was identified intra-op that cautery tip had created a burn on the patient's right chest.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/22/2025.

• Brand Name: E-Z CLEAN BLADE MOD 2.75IN
• 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: 23864197
• Report Number: 1721194-2025-00079
• Device Sequence Number: 10098583
• Product Code: GEI
• UDI-Device Identifier: 10614559100103
• UDI-Public: 10614559100103
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 12/22/2025
• 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
• Patient Age: 74 YR
• Patient Sex: Female