MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN ENDO GIA; STAPLE, IMPLANTABLE

Model Number	EGIATRS45AMT
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2019
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 wedge resection of the lung, the first and the second firing were completed with no problem.For the third firing (the additional resection),they set the device with no problem.The surgeon started the firing and the surgeon felt that it advanced slightly, but it stopped and could not advance any more.They re-connected the cartridge and checked the jaws opening/closing, and the surgeon tried to fire the device, but the same event occurred and could not fire the device.Replaced by new cartridge and set the device, and the firing was completed with no problem.The same handle was used through out the procedure.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the returned product noted that the reload was pre fired with the interlock engaged.Microscopic evaluation noted that the reload had damage to the cutting edge of the knife blade.The buttress was torn from the proximal end on both the anvil and cartridge side.Functionally, the reload was loaded into a post market vigilance instrument, the interlock was overridden, and the reload was cycled without hesitation and was applied to test media.All remaining staples were placed, and test media was cleanly transected.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the damaged knife blade may occur when an obstacle has been incorporated in the jaws during application.The information booklet which accompanies each product shipment cautions the user; ensure that no obstructions (such as clips) are incorporated in the instrument jaws.Firing over an obstruction may result in incomplete cutting action and/or improperly formed staples.The root cause of the observed damage was due to the product not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.Additionally, the investigation detected a secondary condition of torn buttress that has no relationship to the reported condition.Replication of the observed condition can be caused by excessive manipulation of the reload during use which can cause the reinforcement material to tear and/or detach.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8829411
• Report Number: 1219930-2019-04453
• Device Sequence Number: 2859632
• Product Code: GDW
• UDI-Device Identifier: 10884521190887
• UDI-Public: 10884521190887
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133938
• 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): 09/20/2019

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 Expiration Date: 10/31/2020
• Device Model Number: EGIATRS45AMT
• Device Catalogue Number: EGIATRS45AMT
• Device Lot Number: N7K0728KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1