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	Hematoma (1884); Unspecified Infection (1930); Seroma (2069)
Date of Event	11/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Title: clinical outcomes of single incision laparoscopic surgery and conventional laparoscopic transabdominal preperitoneal inguinal hernia repair, source: ilhan ece, huseyin yilmaz, serdar yormaz, mustafa sahin date: 2017, january-march 2017.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the literature source of study performed december 2012 and january 2015, during laparoscopic transabdominal preperitoneal (tapp) inguinal hernia repair is a frequently performed method.A retrospective study by ece et al.Evaluated the safety and feasibility of the single-incision laparoscopic surgery (sils) approach for laparoscopic tapp repair of the inguinal hernia.For tapp, a trocar was introduced through the umbilicus with open technique, with 3 other trocars.The rates of short-term post-operative complications were comparable between the groups; seroma, and hematoma, and all complications were resolved with conservative treatment.Three patients were treated with oral antibiotics for port site infection.Three patients in the sils-tapp group experienced port site hernia (psh).

• 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: 10245390
• Report Number: 1219930-2020-02694
• Device Sequence Number: 13596476
• Product Code: GCJ
• UDI-Device Identifier: 10884523002638
• UDI-Public: 10884523002638
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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: Required Intervention
• Patient Age: 54 YR