(b)(4).Date sent: 4/9/2024.D4: batch # unk.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.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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It was reported that during a laparoscopic myomectomy, when inducing the trocar in the umbilical site, blood spurting from right common ileoartery when viewing it using a camera port.Procedure was converted to open laparotomy to secure bleeding.On march 27, patient was facing bowel injury and had to undergo another laparotomy.Patient is still in hospital currently.
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