MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER SILS PORT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number SILSPT5

Device Problems Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pneumonia (2011); Urinary Retention (2119); Blood Loss (2597); No Code Available (3191)

Event Date 11/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Title: transanal total mesorectal excision (tatme): single-centre early experience in a selected population source: updates in surgery (2019) 71:157¿163 published online: 8 november 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study performed between january and may 2016, study aimed to evaluate the early surgical results following total mesorectal excision to treat rectal cancer.Twelve patients diagnosed with mid-low rectal adenocarcinoma were evaluated with regards demography, histopathology, peri-operative data and postoperative complications.Intraoperative complications were recorded in one case with the failed mechanical anastomosis which was resolved by placing additional interrupted stitches on the suture line.Five out of twelve patients underwent colo-anal anastomosis, 3 handsewn and 2 stapled.The remaining were stapled colorectal anastomoses.All anastomoses were protected with a de-functioning ileostomy.Eleven out 12 patients had less than 200 ml of intraoperative blood loss.They observed the following early post-operative complications 1 case of urinary retention, 1 of pneumonia, 2 skin infections and 2 post-operative ileus.Transanal total mesorectal excision (tatme): single-centre early experience in a selected population michele de rosa1 · fabio rondelli1 · marcello boni1 · fabio ermili1 · walter bugiantella1 · lorenzo mariani1 · graziano ceccarelli1 · antonio giuliani2.

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.

• Brand Name: SILS PORT
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 10287784
• MDR Text Key: 199218376
• Report Number: 1717344-2020-00746
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884523002638
• UDI-Public: 10884523002638
• Combination Product (y/n): N
• PMA/PMN Number: K093372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,user facil
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SILSPT5
• Device Catalogue Number: SILSPT5
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR