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	Unspecified Infection (1930); No Code Available (3191)
Date of Event	04/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, post operatively, on laparoscopic roux-en-y gastric bypass, after creation of the gastrojejunal anastomosis, there was a surgical site infection where the anvil was removed from the abdomen.The events lead to or extended the patient¿s hospitalization for one observation day.Treatment of the surgical site infection was done to resolve the issue.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, five days post operatively, following a laparoscopic roux-en-y gastric bypass, after creation of the gastrojejunal anastomosis, there was a surgical site infection where the anvil was removed from the abdomen.The patient came through emergency room and observed for a day but was not readmitted.Treatment of the surgical site infection was done with oral antibiotics to resolve the issue.

• 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: 7602156
• Report Number: 1219930-2018-03112
• Device Sequence Number: 1694989
• Product Code: GDW
• UDI-Device Identifier: 20884521042862
• UDI-Public: 20884521042862
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K062850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2018

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
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 06/28/2018
• 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; Other; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 132