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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pain (1994)
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Event Date 01/01/2019 |
Event Type
Injury
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Event Description
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Title: short-term clinical efficacy of ivor-lewis and mckeown in the treatment of middle and lower thoracic esophageal carcinoma.The objective of this study is to analyze the recent clinical effects of the ivor-i^wis and mckeown procedures for treating lower middle-chest oesophageal cancer.106 patients with lower middle-thoracic oesophageal carcinoma treated with the endoscopic oesophageal cancer were selected, of which 50 were ivor-lewis (ivor-lewis group) and 56 were mckeown (mckeown group).Johnson straight cut suture was used.Reported complications included severe pain.In conclusion ivor-lewis and mckeown are safe and effective in treating lower middle oesophageal cancer, but ivor-i^wis has fewer complications than mckeown, and patients recover faster and have a better quality of life after surgery.
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Manufacturer Narrative
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(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.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.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? this report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.(b)(4).Device not returned the single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation https://doi.Org/10.3969/j.Issn.1002-266x.2019.16.013.
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Manufacturer Narrative
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(b)(4).Date sent to the fda: 12/27/2022 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.The following information was requested but unavailable: does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics?.
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Search Alerts/Recalls
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