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

Model Number	EEAORVIL25
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Codes	Tissue Damage (2104); Injury (2348); No Code Available (3191)
Date of Event	07/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, on (b)(6) 2017, the patient undergone the procedure of esophagojejunostomy in lap.Total gastrectomy d procedure was completed well.But, after one week they found some food on the drain tube so the patient went back to the hospital as emergency.There are several unformed staples and the tissue was teared.The patient had to undergo a redo the esophagojejunostomy, and they had to cut the anastomosis site.The surgery extended for more than thirty minutes and also there was an extension of the incision site.There was an unanticipated tissue loss as a result of this problem.There was permanent tissue damage as a result of this problem.The patient had extension of hospitalization for seven days due to the event.There was permanent injury as a result of the event.The patient was alive with injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of three photos of device.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Without the physical product, a definitive root cause could not be identified.Post market vigilance will continue to monitor this condition for future potential action.Should new information become available, the file will be re-opened and the investigation will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: as per the additional information received, redo anastomosis using another device.There were no problem during the original surgery.Patient status: discharged.

• Brand Name: EEA ORVIL
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mc dermott rd; north haven CT 06473
• MDR Report Key: 6811351
• Report Number: 1219930-2017-06580
• Device Sequence Number: 11196596
• Product Code: GDW
• UDI-Device Identifier: 10884521042865
• UDI-Public: 10884521042865
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K093402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: EEAORVIL25
• Device Catalogue Number: EEAORVIL25
• Device Lot Number: N5G0134X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 10/11/2017; 11/02/2017
• Initial Report FDA Received Date: 08/22/2017
• Supplement Report FDA Received Date: 10/31/2017; 11/20/2017
• 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; Required Intervention
• Patient Age: 46 YR