MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. 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 Codes	Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported that during a tonsillectomy, they were using a covidian bovie, inserted the tip but was not pushed in correctly/entirely.The exposed metal portion caused the burn of the patient around the lips/mouth.Patient was taken care of without further issues.Customer confident it isn't the product's issue for the cause but wanted to call it in for their standard protocols.Device is available for return.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/29/2024 b3: only event year known: 2024.Investigation summary: 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.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.Additional information was requested, and the following was obtained: what is the severity of the burn? (please see degrees of burns below and choose one).Third degree burn the burn site looks deep, whitening or blackened and charred.What medical intervention was used to treat the burn? (such as salve or stitches) bacitracin ointment applied to bilateral oral commissure.Besides the burn, did the patient experience any adverse consequence due to the issue? no.Are there any anticipated long-term effects from the burn or injury? at first, surgeon thought this could possibly lead to future surgeries.Currently, patient is healing up fine.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: 3/8/2024.A manufacturing record evaluation was performed for the finished device lot/batch number tdmppc.And no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/4/2024.#mw 5151407.It was reported that during tonsillectomy, the megadyne electrode was not properly seeded in the (b)(6) pencil.When the procedure was completed there were two second degree burns on the corners of the patient's mouth.There was no issue with generator, it was just used in the procedure to complete the circuit.The patient had non-serious injury.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/11/2024.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the 0012am electrode was returned with no normal wear.A functional test was performed with a multimeter, and it passed the continuity test as intended.The customer provided a photo showing the electrodes and pencils.The event described could not be confirmed as the devices were returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the devices that could not be replicated during the laboratory analysis.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: E-Z CLEAN BLADE MOD 2.75IN
• Common Device Name: E-Z CLEAN BLADE MODIFIED 2.75 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: kate karberg ; 475 calle c; guaynabo ; PR ; 3035526892
• MDR Report Key: 18807682
• Report Number: 3005075853-2024-01749
• Device Sequence Number: 17977521
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/11/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0012AM
• Device Lot Number: TDMPPC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 03/06/2024; 03/19/2024; 04/05/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 03/08/2024; 04/04/2024; 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2023
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown