(b)(4).Date sent: 8/8/2023.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 serial number was provided therefore a device history could not be done.Additional information received: on (b)(6) 2023, a little child (11 months old) was operated on.The child was lying on the megadyne pad.The surgeons have complained that the monopolar cautery device was not working.This was checked several times, although the device confirmed the contact with ¿green¿.Meanwhile, anesthetic nurse checked relaxation status on the child while touching the child's hand.She could no longer remember if she was touching the electrodes or not (probably not).Suddenly it got very hot, and she had a small burn (degree 1-2a) on the index finger but was able to continue working.The child had no burn marks, and they could complete the procedure.The megadyne pad laid flat on the mattress without contact to any metal parts of the or table.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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