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

Model Number	0010-8118D
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a scheduled preventive maintenance the console started smoking.There was no procedure or patient involved.It was noted that the power supply needs to be replaced.
Additional Manufacturer Narrative
The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.The replaced power supply board was returned to the manufacturer and failure analysis was completed.A visual inspection found that the cover is bent and resistor 78, 89 were found to be damaged and burnt.The wire e12 had burn marks but there was no damage found in the insulation.The complaint smoke was confirmed based on the return of the power supply board and resistor r78 and r89 were found to be damaged and burnt.The cause was traced to a component failure.
Event or Problem Description
It was reported that during a scheduled preventive maintenance the console started smoking.There was no procedure or patient involved.It was noted that the power supply needs to be replaced.

• 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: 7959641
• Report Number: 2937094-2018-60034
• Device Sequence Number: 19267219
• Product Code: GEX
• UDI-Device Identifier: 00878953001678
• UDI-Public: 00878953001678
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 0010-8118D
• Device Catalogue Number: 0010-8118D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 11/10/2018
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1