MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SILS PORT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number SILSPT5

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

Patient Problems Abscess (1690); Hematoma (1884); Urinary Tract Infection (2120); Post Operative Wound Infection (2446); No Code Available (3191)

Event Date 11/16/2015

Event Type  Injury  

Manufacturer Narrative

Title: single-incision laparoscopic surgery for rectal cancer: early results and medium-term oncological outcome | source: k.Gash, m.Bicsak and a.Dixon.Department of colorectal surgery, north bristol nhs trust, southmead hospital, westbury-on-trym, bristol, uk and spire hospital, bristol, uk date: received 5 december 2014; accepted 27 march 2015; accepted article online 16 june 2015.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, (april 2009 to january 2014) this study aimed to evaluate a single-incision laparoscopic surgery for rectal cancer: early results and medium-term oncological outcome.In a prospective study 61 patients underwent sils for rectal cancer using a sils port.An early or late post-operative complication occurred in 12 (19.7%) of the 61 patients: paralytic ileus (3), urinary retention (2), anastomotic bleeding (2), haematoma formation (2), wound infection (1), intraperitoneal abscess (1) and urinary tract infection (1)], and 3 readmissions( 4.9%).

• Brand Name: SILS PORT
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 10245560
• MDR Text Key: 197959750
• Report Number: 1219930-2020-02695
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884523002638
• UDI-Public: 10884523002638
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• 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: 06/19/2020
• 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): Other
• Patient Age: 62 YR