MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. E-Z CLEAN MEGAFINE NDLE 2.5IN; E-Z CLEAN MEGAFINE NEEDLE 2.5 INCH

Model Number	0118A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a t&a procedure the coating around the tip burns off.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/1/2023.Unknown, assumed 1st month of the year that the event took place.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned electrode determined that the 0118a device was returned with a cut in the black insulation at the distal end, exposing the metal substrate.In addition, the coating of the tip electrode was damaged.No insulation detached was observed, the instrument was tested for continuity and passed the test.It is possible that the cause of this damage is a result of the application of excessive mechanical forces such as contact with other instruments or objects that damage the edge of the insulation.For instance, contact with a sharp edge on the trocar during insertion or removal may cut or slice the insulation.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 rkmmbz, and no non-conformances were identified.Additional information was requested, and the following was obtained: could you please confirm if the tip presented any flame, flash or fire (isn¿t limited to sparking or arcing)? no fire or spark.Did the green coating of the device peel off? this tip was steel, no green coating.Did a part of the black insulation detach from the device? yes, the black insulation detached from device.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.

• Brand Name: E-Z CLEAN MEGAFINE NDLE 2.5IN
• Common Device Name: E-Z CLEAN MEGAFINE NEEDLE 2.5 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: 17037425
• Report Number: 3005075853-2023-03638
• Device Sequence Number: 6459467
• Product Code: GEI
• UDI-Device Identifier: 10614559101414
• UDI-Public: 10614559101414
• 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
• Report Date (Section B): 06/01/2023

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 Expiration Date: 08/31/2026
• Device Model Number: 0118A
• Device Catalogue Number: 0118A
• Device Lot Number: RKMMBZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown