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	11/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure the aura console was stuck in the warming up state and showed error 20.The case could not be completed due to this event.There was no patient outcome information reported.

• 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: 8140218
• Report Number: 2937094-2018-60154
• Device Sequence Number: 276951
• Product Code: GEX
• UDI-Device Identifier: 00878953001678
• UDI-Public: 00878953001678
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K951034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/06/2018

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: 11/08/2018
• Initial Report FDA Received Date: 12/06/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other