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

Model Number	EGIA30AV
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Codes	Tissue Damage (2104); Blood Loss (2597); No Code Available (3191)
Date of Event	03/05/2018
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 right upper lobe resection, the surgeon used a stapler at the first firing to interlobar and used another stapler at the second firing to pv with no problem.At the third firing to a1+3, the surgeon used one more device (different lot number).During the firing, he did not have a feel of stapling at all.After he fully fired the device, he and the cardiovascular surgeon manually sutured the bleeding site without open the jaws of cartridge.Blood loss of 7000cc was noted.The patient had received blood transfusion as a result of the issue.However the procedure was completed with no problem.The procedure was converted to an open procedure.The patient hospitalization is extended.The patient is staying at icu and under monitoring and in good progress.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Staples did not deploy during functional testing.The device was disassembled and it was identified that the sled component was missing.A review of the device history record (dhr) indicates this product was released meeting all quality release specifications at the time of manufacture.However, an assembly error was identified during product analysis.The root cause of this failure has been attributed to improper reject disposition by human intervention at an automated assembly station.The product analysis established a relationship between a device failure and the reported incident of staples did not deploy.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.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: 7362410
• Report Number: 1219930-2018-01588
• Device Sequence Number: 1273671
• Product Code: GDW
• UDI-Device Identifier: 20884521186092
• UDI-Public: 20884521186092
• 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
• Report Date (Section B): 06/01/2018

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 Expiration Date: 07/31/2022
• Device Model Number: EGIA30AV
• Device Catalogue Number: EGIA30AV
• Device Lot Number: N7G0757KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Initial Date Received by Manufacturer: 03/05/2018
• Supplement Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 06/01/2018
• 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: Hospitalization; Required Intervention