MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN 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	05/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one reload.Visual examination of the staple cartridge noted that the reload had a full complement of staples.The proximal end of the reload was fractured.Functional testing of the reload could not be performed due to the noted damages.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the damaged reload adapter may occur due to over flexure of the reload while attached to the instrument.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.This event was previously reported to the fda on a summary report and is now being submitted on a 3500 a per fda request.
Event or Problem Description
According to the reporter, during a lobectomy, for the first firing for lobectomy, the nurse connected reload to the handle and checked the jaws opening/closing.Then the surgeon clamped the vessel and tried to squeeze the handle, however the handle was stiff and could not fire the device at all.The procedure was completed with another.Device.The surgical time was extended by less than 30 min.The status of the patient is no problem.

• 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: 7130302
• Report Number: 1219930-2017-10188
• Device Sequence Number: 13928614
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/19/2017

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: 10/31/2021
• Device Model Number: EGIA30AV
• Device Catalogue Number: EGIA30AV
• Device Lot Number: N6K0602KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2017
• Initial Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1