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

Model Number	030450
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	Hemostasis (1895)
Date of Event	09/03/2018
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 lobectomy procedure, the knife moved forward but the staples could not be fired.The procedure was completed with another device.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual examination of the staple cartridge noted that the loading unit was fully fired.The proximal end of the loading unit adapter was broken.Engineering confirmed the presences of staple strikes in the anvil pockets.The staple strikes indicate that staples were present and deployed during the application.Due to the noted damage no functional testing was performed.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.Additionally, the investigation detected a secondary condition of a broken adapter on the loading unit that has no relationship to the reported condition.Replication of broken adapter may occur due to over flexure of the loading unit while attached to the instrument.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 PR 06473 4401
• MDR Report Key: 7912404
• Report Number: 2647580-2018-04727
• Device Sequence Number: 2305234
• Product Code: GDW
• UDI-Device Identifier: 10884523002812
• UDI-Public: 10884523002812
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111825
• 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,Followup
• Report Date (Section B): 02/25/2019

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: 030450
• Device Catalogue Number: 030450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 10/11/2018; 01/30/2019
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 11/05/2018; 02/25/2019
• 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