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 Ischemia (1942); Necrosis (1971)

Event Date 04/29/2015

Event Type  Injury  

Manufacturer Narrative

Title: transanal total mesorectal excision for rectal carcinoma: short-term outcomes and experience after 80 cases source: surg endosc (2016) 30:464¿470 published online: 29 april 2015.If information is provided in the future, a supplemental report will be issued.[(b)(4)].

Event Description

According to the literature source of a study performed between june 2012 to september 2014 about short-term outcomes and experience after 80 cases of transanal total mesorectal excision for rectal carcinoma, in which a single-port device was used, one patient was readmitted 10 days after surgery with circular full-thickness ischemia of the mucosa distal of the anastomosis and in the anal canal, possibly caused by pressure necrosis due to the transanally placed trocar.

• 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: 10245915
• MDR Text Key: 197974156
• Report Number: 1219930-2020-02698
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884523002638
• UDI-Public: 10884523002638
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 66 YR