MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GREENLIGHT XPS LASER SYSTEM; POWERED LASER SURGICAL INSTRUMENT

Model Number	0010-0210R
Medical Device Problem Codes	Smoking (1585); Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a preventative maintenance appointment, the field service engineer (fse) smelt and saw smoke coming from the console.Soon after, error codes 154 and 102.5 were received.There was no patient involved with the event.
Additional Manufacturer Narrative
The console was not returned for analysis.However, this console was serviced at the customer's facility by a field service engineer (fse).The fse confirmed the error code received as well as the seeing and smelling the smoke.The resonator was replaced and all calibrations were performed.The laser was working properly.Based on the information available, the cause of the reported event was traced to a component failure.
Additional Manufacturer Narrative
The console was serviced onsite by a field service engineer (fse).During the visit, the fse confirmed receiving error 154.The resonator was replaced.The console was then calibrated.It passed full functional and electrical safety testing.The resonator was returned and upon receipt at our post market quality assurance laboratory, the device was thoroughly analyzed.Visual analysis was able to replicate the error 154 reported by the fse.It was found that the resonator control board had melted/burned components.The fiber coupler had signs of corrosion, and the power detector values on the board were off.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during a preventative maintenance appointment, the field service engineer (fse) smelt and saw smoke coming from the console.Soon after, error codes 154 and 102.5 were received.There was no patient involved with the event.

• Brand Name: GREENLIGHT XPS LASER SYSTEM
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16765417
• Report Number: 2124215-2023-18367
• Device Sequence Number: 3063750
• Product Code: GEX
• UDI-Device Identifier: 00878953001906
• UDI-Public: 00878953001906
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K092735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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: 0010-0210R
• Device Catalogue Number: 0010-0210R
• Device Lot Number: XPS50764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown