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

Model Number	GIA6048RL
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	04/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: occurred during an open partial gastrectomy.During the duodenal stump and stomach resectioning, the staples did not deploy from the loading units.There was surgical intervention required because the tissue had to be hand sutured.There was no extension in surgical time.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: occurred during an open partial gastrectomy.During the duodenal stump and stomach resectioning, the staples did not deploy from the loading units.The incision was extended due to the product issue.Followed up if the incision was extended more than 1 inch.There was surgical intervention required because the tissue had to be hand sutured.There was no extension in surgical time.

• Brand Name: RELIAMAX
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mc dermott rd; north haven CT 06473
• MDR Report Key: 6697742
• Report Number: 1219930-2017-05961
• Device Sequence Number: 16614841
• Product Code: GDW
• UDI-Device Identifier: 10884521168626
• UDI-Public: 10884521168626
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2018

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: 08/31/2018
• Device Model Number: GIA6048RL
• Device Catalogue Number: GIA6048RL
• Device Lot Number: N5H0907X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 07/10/2017
• Supplement Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1