(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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.What is the total number of procedures, where the needle disengaged from the swage, while the surgeon was closing the wound? for each patient procedure, where the needle disengaged from the swage, please provide the following information: procedure name and date.Product code(s) and lot number(s) of the device(s) where the needle pulled off at the swage.Were there any adverse patient consequences? if so, please clarify any surgical or medical intervention.Did any piece of the needle fall inside of the patient? if so, was the needle piece removed and how? when did the needle pull off (while in the package / during dispensing / during preparation / during use)? have any of these events been previously reported to ethicon? if so, please provide the respective reference number(s).
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