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

Model Number	0118
Medical Device Problem Code	Arcing of Electrodes (2289)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Lot number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.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 open laparotomy the bovie pencil tip caught on fire.A new pencil was used to complete the case with no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/24/2023.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 0118 device was returned with the black insulation melted not all present and the coating of the electrode tip charred.During the visual examination, it was observed along the length of the blue insulation are indentations and other surface markings/scratches indicating that the electrode has come in contact with instrumentation.It is possible that the electrode may have been grasped with other instruments (ie, hemostatic).Evidence suggests that the current has been diverted by a damaged area on the electrode evidenced by the characteristics of being blackened and melted, resulting in the reported event.The instructions for use instruct the user to dispose of damaged electrodes.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 lot: sampcs and no non-conformances were identified.

• 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 16454422
• Report Number: 3005075853-2023-01243
• Device Sequence Number: 20294551
• Product Code: GEI
• UDI-Device Identifier: 10614559101278
• UDI-Public: 10614559101278
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2023

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 Model Number: 0118
• Device Catalogue Number: 0118
• Device Lot Number: SAMPCS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown