(b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.- it was reported that needle almost went inside the patient and there was patient consequences.Did the needle fall into the patient? if yes, ¿ was the needle retrieved during the same procedure? ¿ were x-rays taken to locate the needle? ¿ what measures were taken to retrieve the needle? ¿ was there any additional tissue damage as a result of searching for the needle? - does a piece of the needle remain in the patient¿s tissue? if yes, ¿ is there any plan in place to remove the needle in the future? ¿ if yes, please provide the scheduled date.¿ what tissue structure the needle was located? ¿ what is the surgeon's opinion of consequences to the patient? - were there any unexpected outcomes or complications as a result of the prolonged surgery time? - what tissue was being sutured when the event occurred? - was additional dissection required in other organs/tissues other than the target tissue? - was there any change in the patient¿s post operative care due to the prolonged procedure? attempts are being 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.H6 component code: g07002 ¿ device not returned.Related events captured via: 2210968-2024-03419, 2210968-2024-03420, 2210968-2024-03421, 2210968-2024-03422, and 2210968-2024-03423.
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