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Product complaint # (b)(4).H3 investigation summary: the product was returned to eth for evaluation.Visual inspection revealed that one needle suture in two sections and one empty labeled winding former were received for analysis.Product code sxpp1b420.Upon visual inspection of the returned sample, pronounced tooling marks were observed on the body needle.Examination of the suture pieces revealed that their ends appeared to have been cut, most likely with a surgical instrument.Body fluids and crimping marks were present in some suture segments.Additionally, the loop was inspected and no abnormalities were found during the evaluation.As the suture is absorbable and the duration and conditions of environmental exposure could not be determined, functional testing was not performed.To prevent this kind of damage: care should be taken to avoid damage to the strand when handling, including avoiding the crushing or crimping action of surgical instruments such as needle holders and forceps.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, and the following was obtained via: - please provide the lot number.=>unk.- please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.=>the device has been received at sukagawa and will be shipped.Please check rmao.Tracking number is (b)(6) - provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq).=>(b)(6).
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It was reported that a patient underwent a distal gastrectomy procedure on (b)(6) 2026 and barbed suture was used.During the procedure, it was reported by a sales rep that, during a robot-assisted distal gastrectomy, the doctor noticed an abnormality in the loop shape the suture at the proximal end during use and use was stopped.It could confirm that the suture was broken about 3 centimeters from the loop, but it couldn't visually detect any abnormality in the loop shape when the sales rep checked the product.It was not a control release needle.Another product was used to complete the case.When we send the sample to you, we will let you know its return date and tracking number.There were no adverse consequences to the patient.Further details are not provided from the hp.No adverse patient consequences were reported.Additional information was requested.4.Please take photos for japanese customer.
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