MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN 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	Abscess (1690); Hematoma (1884); Urinary Tract Infection (2120); Post Operative Wound Infection (2446); No Code Available (3191)
Date of Event	11/16/2015
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 10245560
• Report Number: 1219930-2020-02695
• Device Sequence Number: 573443
• Product Code: GCJ
• UDI-Device Identifier: 10884523002638
• UDI-Public: 10884523002638
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/08/2020

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