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

Model Number	030775
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: no specific issue was reported.Evaluation found a disengaged cartridge and the fastner was observed to be broken out of the channel.An adequate amount of glue was noted.No visual or functional abnormalities were noted.A review of the device history record indicates the product was released meeting all medtronic quality release specifications at the time of manufacture.Replication of the observed condition may be due to rough handling of the device.The root cause of the observed damage was misuse of the product.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Product was returned without a reported issue.Examination of the returned sample found a disengaged cartridge and a broken fastener.

• Brand Name: POLY GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• MDR Report Key: 7316615
• Report Number: 1219930-2018-01288
• Device Sequence Number: 1424171
• Product Code: GDW
• UDI-Device Identifier: 10884521047679
• UDI-Public: 10884521047679
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2018

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: 09/01/2017
• Device Model Number: 030775
• Device Catalogue Number: 030775
• Device Lot Number: N5C0695X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1