MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN EEA ORVIL; STAPLE, IMPLANTABLE

Model Number	EEAORVIL25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); No Code Available (3191)
Date of Event	04/23/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Title: "minimally invasive oesophagectomy: preliminary results after introduction of an intrathoracic anastomosis." source: digestive surgical, 2014 (95-103).Date of publication: 23 april 2014.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to literature source of study performed from january 2011 until august 2012, a total of 45 operable patients were scheduled to undergo minimally invasive esophagectomy (mie) with intrathoracic anastomosis.Nine of the 45 patients were under group 1 wherein a circular stapler with an oral anvil was used to create the intrathoracic anastomosis.Four of the nine patients had an anastomotic leak and underwent re-operation while one patient was re-admitted to the hospital.Six patients had developed pulmonary complications; five patients developed cardiac complications and three patients were readmitted to the icu.

• Brand Name: EEA ORVIL
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8420101
• Report Number: 1219930-2019-01514
• Device Sequence Number: 16593048
• Product Code: GDW
• UDI-Device Identifier: 20884521042862
• UDI-Public: 20884521042862
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K062850
• 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): 03/14/2019

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: EEAORVIL25
• Device Catalogue Number: EEAORVIL25
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 03/14/2019
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 66 YR