MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. E-Z CLEAN NEEDLE MOD 2.75IN; E-Z CLEAN NEEDLE MODIFIED 2.75 INCH

Catalog Number	0013M
Medical Device Problem Code	Arcing of Electrodes (2289)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 1/11/2024.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.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.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 the removal of infected hardware that while using coag on setting of 30/30 along with a metal forceps the bovie tip caught fire but did not spark.The tip was replaced and the procedure was completed with the same pencil and generator.There were no adverse consequences for the patient, surgeon, and staff.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/30/2024.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/22/2024.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the 0013m device was returned with the tip of the electrode melted and charring present.The most likely cause of this damage is caused by operating the electrosurgery equipment (generator) at high power settings with continual activation of the electrode for long periods or by placing the electrode tip against another instrument causing the event reported which results in the melting of the tip.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch rcmlxh, and no non-conformances were identified.

• Brand Name: E-Z CLEAN NEEDLE MOD 2.75IN
• Common Device Name: E-Z CLEAN NEEDLE 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: 18491944
• Report Number: 3005075853-2024-00283
• Device Sequence Number: 14336050
• Product Code: GEI
• UDI-Device Identifier: 10614559100134
• UDI-Public: 10614559100134
• 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
• Report Date (Section B): 02/22/2024

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: 0013M
• Device Lot Number: RCMLXH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/28/2023
• Supplement Date Received by Manufacturer: 01/19/2024; 02/16/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 01/30/2024; 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2023
• 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
• Patient Sex: Unknown