MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN - MFG ENDO GIA; STAPLE, IMPLANTABLE

Model Number	EGIA30AV
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter: during thoraco/lobectomy, they connected cartridge to handle for the third firing for resection of right upper lobe of lung, the surgeon tried to fire the device, however could not.Replaced by a new cartridge, the procedure was completed with no problem.The status of the patient: no problem.

• Brand Name: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN NORTH HAVEN - MFG; 195 mcdermott road; north haven CT 06473
• MDR Report Key: 6771627
• Report Number: 1219930-2017-06206
• Device Sequence Number: 11202506
• 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
• Report Date (Section B): 07/07/2017

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: 01/31/2022
• Device Model Number: EGIA30AV
• Device Catalogue Number: EGIA30AV
• Device Lot Number: N7A0342KX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 08/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1