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 Codes	Flaked (1246); 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
Additional Manufacturer Narrative
(b)(4).Date sent: 5/17/2023.Only event year known: 2023.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.No lot or batch number was provided therefore a device history could not be done.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)? did the green coating of the device peel off? did a part of the black insulation detach from the device? answer - no fire or spark this one did not have any green coating 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.
Event or Problem Description
It was reported that during an unknown procedure the coating around the tip burns off.There were no patient consequences.

• 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: 16944958
• Report Number: 3005075853-2023-03345
• Device Sequence Number: 11309926
• 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): 05/17/2023

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: 0118A
• Device Catalogue Number: 0118A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown