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

Model Number	EEAORVIL25
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Difficult to Remove (1528)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/28/2018
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, during a total gastrectomy, while being applied at the anastomosis, jejunum and esophagus, the anvil from a stapler did not match with the device because the trocar went backwards and the knob turned it self alone.The surgeon decided to proceed with an open procedure instead of laparoscopic one, and again tried to match the same anvil with the same device, but same situation happened with the trocar and knob.Because of the long esophagus manipulation with this matching action, the tissue was affected and a stent had to be implanted and the anastomosis was hand sewn.The anvil could not be tilted after firing and the surgical time was extended for more than 30 minutes.To resolve the issue, the surgeon reviewed the steps to use the product and also talked to the clinical and product specialist regarding the steps to follow.The patient had incurred a temporary injury.

• Brand Name: EEA ORVIL
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• MDR Report Key: 7597990
• Report Number: 1219930-2018-03076
• Device Sequence Number: 19129534
• Product Code: GDW
• UDI-Device Identifier: 20884521042862
• UDI-Public: 20884521042862
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2018

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2018
• Initial Report FDA Received Date: 06/13/2018
• 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: Required Intervention
• Patient Age: 55 YR