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

Model Number	EGIA30CTAV
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient code - (b)(4).A hemostasis treatment was performed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during lung resection, the doctor started firing the first reload at the time of vein treatment, when an onomatopoeic sound was heard at the tip of the reload, even when the doctor fired to the end and returned the knife, from near the tip to the middle until the knife returned, onomatopoeic sound was heard.As a result, the tip part of the staple line was not formed and oozing bleeding occurred as a result of the issue.A hemostasis treatment was performed.A similar event occurred when the second reload was used on the lung pulmonary parenchyma.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of a device.The visual and functional evaluation of the reload found no abnormalities.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.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: 7947106
• Report Number: 1219930-2018-05388
• Device Sequence Number: 11178885
• Product Code: GDW
• UDI-Device Identifier: 10884521186101
• UDI-Public: 10884521186101
• 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): 12/13/2018

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 Model Number: EGIA30CTAV
• Device Catalogue Number: EGIA30CTAV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Initial Date Received by Manufacturer: 09/15/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 12/13/2018
• 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: Required Intervention