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

Model Number	GIA6038RL
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/21/2018
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, while using the second cartridge during the open total gastrectomy, the device did not fire.The surgeon could not push the firing knob and got stuck.The surgeon opened and used another cartridge to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.There were no visual or functional abnormalities noted during analysis.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 failures.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: RELIAMAX
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7666589
• Report Number: 1219930-2018-03659
• Device Sequence Number: 16548849
• Product Code: GDW
• UDI-Device Identifier: 20884521168616
• UDI-Public: 20884521168616
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K122781
• 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,Followup
• Report Date (Section B): 10/02/2018

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: 03/31/2020
• Device Model Number: GIA6038RL
• Device Catalogue Number: GIA6038RL
• Device Lot Number: N7C0631X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 07/20/2018; 08/08/2018
• Initial Report FDA Received Date: 07/06/2018
• Supplement Report FDA Received Date: 08/06/2018; 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1