(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.To date it has been reported that the device will not be 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.
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It was reported that a patient underwent a robot assisted urological procedure on (b)(6)2024; and a suture was used.During the procedure, the device could not be clipped on the suture.It was attempted to close on suture several times, but the clip could not be closed on the suture.Another like device was used to complete the case.There were no adverse consequences to the patient.No additional information was provided.
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