MAUDE Adverse Event Report: US SURGICAL PUERTO RICO RELIAMAX; STAPLE, IMPLANTABLE

Model Number	GIA6038RL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2017
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: there are non-hemostatic issues with bleeding edges with the stapler.

• Brand Name: RELIAMAX
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce 00716 -440
• MDR Report Key: 7025021
• Report Number: 2647580-2017-07726
• Device Sequence Number: 16619696
• Product Code: GDW
• UDI-Device Identifier: 20884521168616
• UDI-Public: 20884521168616
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• PMA/510(K) Number: K122781
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/13/2017

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: 04/30/2018
• Device Model Number: GIA6038RL
• Device Catalogue Number: GIA6038RL
• Device Lot Number: N5D0214AX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 11/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1