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

Model Number	GIA8038RL
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2018
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, during colectomy functional end to end anastomosis, the device was taken out and when setting the cartridge to the stapler for the first firing, although it could be loaded completely, the stapler could not be closed.The physician made the stapler closed and fired successfully, however the cause of the issue was unknown.After the 2nd cartridge was loaded, the handle was combined with the upper and lower part normally.The device was not used in patient.The surgical time was extended by less than 30 minutes.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection and functional testing confirmed there were no abnormalities that would have caused or contributed to the reported condition.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.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: 8047017
• Report Number: 1219930-2018-05902
• Device Sequence Number: 13819043
• Product Code: GDW
• UDI-Device Identifier: 10884521168633
• UDI-Public: 10884521168633
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122781
• 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,Followup
• Report Date (Section B): 01/14/2019

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: 08/31/2020
• Device Model Number: GIA8038RL
• Device Catalogue Number: GIA8038RL
• Device Lot Number: N7H0942X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 01/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1