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

Model Number	EEAORVIL25
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2019
Type of Reportable Event	Malfunction
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 robotic assisted laparoscopic total gastrectomy.Oral anvil was placed at the esophageal stump during r-y reconstruction and the handle was inserted at the jejunum side.Center rod was extended and was connected to the anvil.It was visually confirmed that the anvil was inserted until the orange band, but when trying to connect the handle and the anvil, but the anvil disconnected in the middle.After the same process was repeated, grasping forceps were used to help prevent the anvil from disconnecting, and the handle and the anvil were connected somehow.The surgical time was extended by less than 30 min.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the staple guide noted the instrument was fully applied.The returned orvil anvil was observed to be tilted and attached to the instrument.Further inspection of the anvil cutting ring showed deep traces of knife impression and the ring was received completely severed.Functionally, the device was subjected to a measured anvil retention test with an acceptable result.The device was applied over the appropriate test media producing acceptable results.The knife cut the test media cleanly and completely, and the pushers advanced.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.The information for use booklet warns the user that when opening the stapler, prior to removal, not to turn the twist knob more than two full turns, as this may allow the anvil assembly to separate from the instrument.If information is provided in the future, a supplemental report will be issued.

• 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: 8622590
• Report Number: 1219930-2019-03010
• Device Sequence Number: 13951430
• Product Code: GDW
• UDI-Device Identifier: 20884521042862
• UDI-Public: 20884521042862
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 05/19/2019
• Supplement Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR