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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Paresis (1998); Insufficient Information (4580)
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Event Date 05/30/2022 |
Event Type
Injury
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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).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events reported via 2210968-2022-08468.Citation: langenbeck's archives of surgery (2022) 407:2151¿2159.
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Event Description
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Title: single-layer continuous duct-to-mucosa pancreaticojejunostomy: ¿how we do it¿.The aim of the current study was to evaluate the feasibility of our simplified technique, single-layer continuous duct-to mucosa pancreaticojejunostomy.From january to february 2020, 20 patients who underwent whipple¿s procedure with the new technique performed by a single surgeon were included in the study.There were 13 male and 7 female patients with a mean age of 66 years (range 47-79 years) and a mean bmi of 24.2 kg/m2 (range 20.7-29.1).During the whipple¿s procedure, hepatojejunostomy was performed using 4¿0/5¿0 pds-ii suture (ethicon).Ante-colic gastrojejunal anastomosis was accomplished by a circular stapler (unknown manufacturer).Hemostasis at the pancreatic stump was secured with transfixion with 5¿0 prolene (ethicon) before the start of pancreaticojejunostomy.A single 4¿0 prolene 26 mm, 1/2c double ends suture (ethicon) was used for the entire continuous duct-to-mucosa pancreaticojejunostomy anastomosis.The reported complications included postoperative pancreatic fistula (n=2), biochemical pancreatic leak (n=3), intraabdominal infection (n=2), delayed gastric emptying (n=4), post-pancreatectomy hemorrhage (n=1), chyle leak (n=3).In conclusion, single-layer continuous duct-to-mucosa pancreaticojejunostomy is a simplified and feasible method for pancreatic anastomosis.Further studies are warranted to evaluate the indications or contraindications and efficacy of preventing pancreatic fistula with our new technique.
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Search Alerts/Recalls
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