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

Model Number	GIA60RS
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2019
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 a sigmoidectomy procedure, at the first firing, when the device was about to be fired, the safety lock got functional and the device was unable to be fired.It was unusable.The procedure was completed with another device.The event occurred during the procedure but the product was not used for patient.No patient injury.

• Brand Name: RELIAMAX
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 8430527
• Report Number: 2647580-2019-01437
• Device Sequence Number: 222384
• Product Code: GDW
• UDI-Device Identifier: 10884521174894
• UDI-Public: 10884521174894
• 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: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/18/2019

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 Model Number: GIA60RS
• Device Catalogue Number: GIA60RS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1