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 Consequences Or Impact To Patient (2199)
Date of Event	10/29/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to the procedure, while the patient was going through a breathing treatment and the laser was going through the warm up sequence, the nurse noted that the operating room was smokey and had a stinky odor.The laser was turned off and taken outside the operating room.The procedure was performed and completed by unknown alternative method.There was no patient injury due to the reported event.

• 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: 8125138
• Report Number: 2937094-2018-60107
• Device Sequence Number: 16574631
• Product Code: GEX
• UDI-Device Identifier: 00878953001678
• UDI-Public: 00878953001678
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K951034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/03/2018

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: Health Professional
• Device Model Number: 0010-8118D
• Device Catalogue Number: 0010-8118D
• Device Lot Number: A1938
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 12/03/2018
• Patient Sequence Number: 1