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 Hematoma (1884); Unspecified Infection (1930); Seroma (2069)

Event Date 11/30/2016

Event Type  Injury  

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 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
• 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: 10245390
• MDR Text Key: 197957937
• Report Number: 1219930-2020-02694
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884523002638
• UDI-Public: 10884523002638
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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): Required Intervention
• Patient Age: 54 YR