|
Model Number SILSPT5 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Arthritis (1723); Atrial Fibrillation (1729); Phlebitis (2004); Post Operative Wound Infection (2446)
|
Event Date 01/28/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
Title: comparison between the perioperative results of single-access and conventional laparoscopic surgery in rectal cancer source: asian j endosc surg 9 (2016) 44¿51.Accepted 5 october 2015.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the literature source of study, laparoscopic surgery for rectal cancer has low rates of morbidity and mortality and achieves comparable pathologic outcomes.The purpose of the study was to compare post-operative outcomes of single-access laparoscopic surgery which was performed among 35 patients using the sils port or glove port-single port, compared with conventional laparoscopic surgery which was performed among 36 patients which used the linear stapler.Post-operative complications occurred in 9 total patients.In the sals group, there was one case each of wound infection, exacerbation of gouty arthritis, thrombophlebitis, and atrial fibrillation in different individuals, and there were two cases of delirium.In the cls group, there were two cases of wound infection and one of thrombophlebitis.Pain scores were significantly higher in the cls group at both 24 and 48 h.
|
|
Manufacturer Narrative
|
This event has been reassessed and found to be a non-mdr reportable complaint.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|
|
|