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	07/03/2019
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 thoraco/lobectomy, the fifth firing stopped when resecting the bronchus.When the screen was checked, the screen was dark and as it was unclear what was displayed, there was no excessive force indicator.It was noted that the jaws root clamped without problem when checked by thoracoscope camera.A new reload was opened and the firing was completed.The extended surgery time was about 5 minutes.There was no patient injury.

• 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: 8813480
• Report Number: 1219930-2019-04305
• Device Sequence Number: 11409880
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/22/2019

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: 11/30/2021
• Device Model Number: EGIATRS45AMT
• Device Catalogue Number: EGIATRS45AMT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2019
• Initial Report FDA Received Date: 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1