MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC AURA XP LASER SYSTEM; POWERED LASER SURGICAL INSTRUMENT

Model Number	0010-8118D
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	03/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during preparation for a prostate procedure the console displayed error 40.The console was rebooted completely and error 42 was displayed.The error could not be resolved and the procedure was aborted.No patient outcome information was provided.

• Brand Name: AURA XP LASER SYSTEM
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC; 3070 orchard drive; san jose CA 95134
• MDR Report Key: 8478121
• Report Number: 2937094-2019-60441
• Device Sequence Number: 1633944
• Product Code: GEX
• UDI-Device Identifier: 00878953001678
• UDI-Public: 00878953001678
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K951034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 0010-8118D
• Device Catalogue Number: 0010-8118D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 04/03/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other