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

Model Number	030450
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/14/2018
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, pre-operatively, the stapler was unable to fire.They noted that they were able to press the green button and squeeze the handle.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual examination noted that the loading unit was received with a full complement of staples.Functional evaluation of the loading unit 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.Analysis concluded there were no assembly component related condition.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, pre-operatively, the stapler was unable to fire.They noted that they were able to press the green button and squeeze the handle.They changed a new one in order to resolve the issue.There was no patient involvement.

• Brand Name: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN - MFG; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7525937
• Report Number: 1219930-2018-02731
• Device Sequence Number: 1529040
• Product Code: GDW
• UDI-Device Identifier: 10884523002812
• UDI-Public: 10884523002812
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2018

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: 11/30/2022
• Device Model Number: 030450
• Device Catalogue Number: 030450
• Device Lot Number: N7L0306KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 09/08/2018
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1