(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.
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