(b)(4).Batch # unk.Additional information was requested and the following was obtained: "please clarify how ¿oozing occurred¿.Did device cut the vessel? no further information will be available.Did a clip cut the vessel? if yes, how was the bleeding controlled? no further information will be available.What amount of blood loss (mls) occurred? no further information will be available.Was a transfusion required? no transfusion performed.No further information will be available.Was there any change to the procedure as a result of the event? no further information will be available.Were there any patient consequences? if yes, please describe.No further information will be available." "the procedure was laparoscopic sigmoidectomy, the device was used on the ima.The clip was formed properly.Astriction was performed to the oozing and additional firing was performed.The patient is stable after the operation, no complication was developed." an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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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