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Product complaint # (b)(4).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.The following information was requested, but unavailable:
was there any reported patient or user harm? unknown.Was there a significant delay? unknown.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.Please confirm if this product w8718, lot 102pmb belongs to the reported event.If yes, please confirm the number of devices of product w8718, lot 102pmb, involved in the reported event.When did the alleged deficiency occur (removal from package / during handling prior to use on patient/ during passage through tissue/during tying / post-op)? if different, please explain.How many devices demonstrated the alleged deficiency? please specify below:
product code w8718, lot 10d6m4:
product code epm8733, lot sgbjac:
did this event contribute to any patient adverse event? if yes, please explain.Photo investigation summary.This is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: two photographs were submitted for analysis.The photos shows open package unit with epm8733 product codes, the lot number sgbjac, expiration date 2027-05-31.The image is not clear to determine the failure mode or the reported condition.As the device was not returned, an analysis investigation could not be performed.Based on the photo review, the event reported is not confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the device was not returned our evaluation is limited.We value the opportunity to fully analyze the device upon its return.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.We value your assistance in providing us an opportunity to evaluate the reported event as all information reported to our company is critical to our continuous improvement efforts.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.Device history review.A manufacturing record evaluation was performed for the finished device batch sgbjac, epm8733-19 and no non-conformances were identified.Mfg.Date - 06/27/2022 exp.Date - 05/31/2027.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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