MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. E-Z CLEAN MEGAFINE NEEDLE 2IN; E-Z CLEAN MEGAFINE NEEDLE 2 INCH

Catalog Number	0118
Medical Device Problem Codes	Failure to Disconnect (2541); Detachment of Device or Device Component (2907); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent 7/18/2025 #mw5172030 b3: only event year known: 2025 an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.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; patient received burns on inner and outer mouth from cautery.A needle tip bovie was used and patient was grounded on left lateral thigh with bovie pad.Surgeon noticed that bovie tip wasn't properly insulated and that a part of the insulated portion was missing, however the burns seem to come from the white insulated part of the bovie pencil that was resting on the patient lip in between uses.It would seem that there was a malfunction with the bovie pencil itself because upon changing the bovie tip the same issue reoccurred with the patient being burned around the mouth.As a result, a new bovie pencil was instead opened and the issue was resolved.At the end of surgery noticeable burns were noted on inside and outside mouth areas.And surgeon requested bacitracin ointment to be applied before going to pacu.Surgeon was informed that the patient had sustained burns on inner and outer mouth from electrocautery pencil.The surgeon noticed that the needle tip bovie was not properly insulated and some parts were missing.A new pencil was provided and the issue was resolved.The malfunctioning pieces were saved and pictures were taken.Bacitracin ointment was ordered before transferring the patient to pacu.

• Brand Name: E-Z CLEAN MEGAFINE NEEDLE 2IN
• Common Device Name: E-Z CLEAN MEGAFINE NEEDLE 2 INCH
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO SURGERY INDEPENDENCIA; chihuahua ; MX
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 22545936
• Report Number: 3005075853-2025-05697
• Device Sequence Number: 18324675
• Product Code: GEI
• UDI-Device Identifier: 10888277377950
• UDI-Public: (01)10888277377950(17)280630(10)THMKEZ
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/18/2025

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: 0118
• Device Lot Number: THMKEZ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2023
• 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: 35 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic