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

Catalog Number	0012M
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an unknown procedure the bovie tip where pencil cautery holds the tip, there was a perforation in the protective insulation of the tip.When used it came into contact with the patient's skin and created a minor burn at the surgical incision site.Surgeon was able to remove affected area at the edge of the incision.Immediately switched out bovie tip.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/4/2026.D4 batch #: unknown.H10: mw5182519.Attempts are being made to obtain the following information.To date, no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent: what was the surgical procedure that was being done? what was the proximity of the burn to the incision site? how large was the burn? what was the degree of the burn? is a photo of the burn available for review? was the post-operative care of the patient altered in any way due to the burn they experienced? was the affected tip the original bovie tip in the device or was it inserted intra-op? was the bovie tip removed and reinserted? if so, how was that done? what instrumentation was used to remove and insert the bovie tip? can you provide more information about the shape, size, and location of the damaged/perforation of the insulation? what is the patient¿s current status? 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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/26/2026.Corrected data: h6 medical device problem code.Additional information was requested and the following was obtained: what was the surgical procedure that was being done? right partial mastectomy with intraoperative ultrasound-guided wire localization.What was the proximity of the burn to the incision site? a cosmetic periareolar incision was made.A burn was noted adjacent to the incision site.How large was the burn? the burn was very small and since it was adjacent to the incision.It was able to be removed.What was the degree of the burn? 1st degree to the best of their knowledge however since it was cut away it's hard to say.Is a photo of the burn available for review? no.Was the post-operative care of the patient altered in any way due to the burn they experienced? no.Was the affected tip the original bovie tip in the device or was it inserted intra-op? in place.Was the bovie tip removed and reinserted? no - it appears that this occurred at the start of the procedure.If so, how was that done? what instrumentation was used to remove and insert the bovie tip? na.Can you provide more information about the shape, size, and location of the damaged/perforation of the insulation? the bovie tip was removed from the field, all lot# associated with the number, removed from, and given to business manager to send to vendor.The minor burn was next to surgical incision and was excised from the wound.What is the patient¿s current status? unaffected by event.

• Brand Name: MEGADYNE
• 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: 24507196
• Report Number: 1721194-2026-00008
• Device Sequence Number: 18670788
• Product Code: GEI
• UDI-Device Identifier: 10614559100110
• UDI-Public: (01)10614559100110(17)300731(10)A98N3A
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/04/2026

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: 0012M
• Device Lot Number: A98N3A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2025
• 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 Sex: Female
• Patient Weight: 61 KG
• Patient Race: White