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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Paresis (1998); Renal Failure (2041); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)
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Event Date 08/19/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.The single complaint was reported with multiple events.There are no additional details, demographics regarding the additional events.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.1.Does the author/surgeon believe that ethicon products (pds suture and prolene suture) involved caused and/or contributed to 90 day mortality in 4 patients? 2.Does the author/surgeon believe that ethicon products (pds suture and prolene suture) involved caused and/or contributed to non-death cases with post-op complications (90-day readmission, reoperation, tumor recurrence, postoperative complication, pancreatic fistula, biochemical leak, delayed gastric emptying, bile leakage, post-pancreatectomy hemorrhage, intraperitoneal fluid collection, surgical site infection, ileus, deep venous thrombosis, acute renal failure, post-operative hemorrhage, abdominal fluid collection, tumoral invasion) described in the article? please specify.3.Does the author/surgeon believe there was any deficiency with the ethicon products (pds suture and prolene suture) used for all cases in this study? 4.If yes, please provide patient demographics for 90 day mortality cases (4 patients) and non-death cases with post-op complications (90-day readmission, reoperation, tumor recurrence, postoperative complication, pancreatic fistula, biochemical leak, delayed gastric emptying, bile leakage, post-pancreatectomy hemorrhage, intraperitoneal fluid collection, surgical site infection, ileus, deep venous thrombosis, acute renal failure, post-operative hemorrhage, abdominal fluid collection, tumoral invasion)? 5.Were all these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.6.Would the author/surgeon like to speak with ethicon medical safety and engineering via scheduled conference call regarding the products involved in the 90 day mortality (4 patients) ? 7.What was a cause of 90 day mortality in 4 patients? please specify.8.Has an autopsy been performed for death case? if so, can the results be shared? 9.Please specify product codes/lot numbers used in this study ( 5¿0 prolene running suture, a double running suture of 5¿0 prolene, a 5¿0 polypropylene suture (prolene) and a 4¿0 polydioxanone suture (pds ii))? citation: surgical oncology 35 (2020) 344¿350.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Events were submitted via 2210968-2021-10538, 2210968-2021-10542 and 2210968-2021-10544.
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Event Description
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Title: robotic-assisted pancreaticoduodenectomy with vascular resection.Description of the surgical technique and analysis of early outcomes we investigated the safety and feasibility of the robotic pancreaticoduodenectomy with venous resection/reconstruction (rpd smv/pv).Since march 2013 to october 2019, a total of 73 rpd and 10 rpd smv/pv were performed.There were 83 patients (48 males and 35 females).A 5¿0 prolene running suture was used for a partial venous excision/tangential resection followed by a patch venorraphy.An endto- end anastomosis is fashioned employing two black diamond micro forceps¿ and a double running suture of 5¿0 prolene.The reconstructive phase used a 5¿0 polypropylene suture (prolene, ethicon, cincinnati, oh, usa) and an interrupted 4¿0 polydioxanone suture (pds ii, ethicon, cincinnati, oh, usa).(n=6) 90-day readmission, (n=8) reoperation, (n=13) tumor recurrence, (n=48) postoperative complication, (n=20) pancreatic fistula, (n=20) biochemical leak, (n=11) delayed gastric emptying, (n=3) bile leakage, (n=3) post-pancreatectomy hemorrhage, (n=3) intraperitoneal fluid collection, (n=1) surgical site infection, (n=1) ileus, (n=1) deep venous thrombosis, (n=1) acute renal failure, (n=1) post-operative hemorrhage, (n=1) abdominal fluid collection, (n=5) tumoral invasion rpd with smv-pv is associated with increased operative time, estimated blood loss, higher major complication rate compared with rpd.
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Manufacturer Narrative
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Product complaint # (b)(4).Additional information: h6 health effect - clinical code, h6.Health effect - impact code: f07 - tumor recurrence , postoperative complication, biochemical leak , bile leakage, and tumoral invasion 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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Search Alerts/Recalls
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