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

Model Number SILSPT5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure to Anastomose (1028); Infarction, Cerebral (1771); Sepsis (2067); Blood Loss (2597); Radiation Exposure, Unintended (3164); No Code Available (3191)

Event Date 02/01/2015

Event Type  Injury  

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 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
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 10249732
• MDR Text Key: 198082357
• Report Number: 1717344-2020-00710
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884523002638
• UDI-Public: 10884523002638
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K093372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• 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: 06/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR