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

Model Number	SILSPT5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Infarction, Cerebral (1771); Sepsis (2067); Blood Loss (2597); Radiation Exposure, Unintended (3164); No Code Available (3191)
Date of Event	02/01/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A step toward notes total mesorectal excision for rectal cancer: endoscopic transanal proctectomy annals of surgery volume 261: 228¿233, number 2, february 2015.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to literature source of study performed from february 2010 to june 2012, previous publications have suggested that endoscopic transanal proctectomy (etap) is a promising technique and may be an alternative to conventional low anterior resection for rectal cancer.The aim of this study was to evaluate the technical feasibility of etap, using port devices.Fifty-six consecutive patients (41 men) underwent etap.The port was used in 11 cases; however, complications were not reported by a single-port device.The overall post-operative complication rate was 26% (14/56).Three patients developed a clinical anastomotic leakage that did not require reoperation.Three additional patients were diagnosed with pelvic sepsis without evidence of anastomotic leak (2 of them required drainage under ct scan), 5 patients experienced transient urinary disorders, 2 patients required red blood cell transfusion during the postoperative course, and a (b)(6)-year-old woman suffered from a cerebral infarction with a favorable outcome.The median hospital stay was 10 days.Article: jean-jacques tuech, 2015, annals of surgery volume 261, number 2.

• Brand Name: SILS PORT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 10249732
• Report Number: 1717344-2020-00710
• Device Sequence Number: 11432649
• Product Code: GCJ
• UDI-Device Identifier: 10884523002638
• UDI-Public: 10884523002638
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K093372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SILSPT5
• Device Catalogue Number: SILSPT5
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2020
• Initial Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR