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	Ischemia (1942); Necrosis (1971)
Date of Event	04/29/2015
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• 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: 10245915
• Report Number: 1219930-2020-02698
• Device Sequence Number: 10905929
• Product Code: GCJ
• UDI-Device Identifier: 10884523002638
• UDI-Public: 10884523002638
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: 66 YR