MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AURA XP LASER SYSTEM; POWERED LASER SURGICAL INSTRUMENT

Model Number	0010-8118D
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure the ktp laser scope was broken.The patient was present and unknown if sedated.The procedure was aborted due to the issue with the scope.No further information was provided.

• Brand Name: AURA XP LASER SYSTEM
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10305192
• Report Number: 2937094-2020-00630
• Device Sequence Number: 11432725
• Product Code: GEX
• UDI-Device Identifier: 00878953001678
• UDI-Public: 00878953001678
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/21/2020

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 07/21/2020
• Patient Sequence Number: 1