MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS GREENLIGHT XPS; POWERED LASER SURGICAL INSTRUMENT

Model Number	0010-0210
Medical Device Problem Codes	Smoking (1585); Device Displays Incorrect Message (2591); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the completed udi and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during mid procedure, the console made a very loud bang and burning smell was noted.The console displayed error e235 (no lps current).Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the completed udi and other product specific information.If additional details become available, a supplemental report will be submitted.Correction block g2.Source has been correct to other.The console was serviced by the field service engineer (fse) at the customer's site.During visual inspection it was found that the laser power supply (lps) was damaged and needed to be replaced.It was noted that the system was turned on, however there was no countdown.Upon further inspection it was found that the laser power supply (lps) was damaged and needed replacement.It was noted that the voltage select board (vsb) and the water reservoir both needed to be replaced along with the lps.The vsb, lps and water reservoir were replaced.The console passed full functional and electrical safety testing.The console works properly according to all boston scientific specifications.The event experienced by the customer was likely caused by the damaged lps.The vsb and lps were returned.Upon receipt of the vsb and lps at our quality assurance laboratory, these devices were thoroughly analyzed.Both the vsb and lps passed visual inspection, however they both failed function testing.
Event or Problem Description
It was reported that during mid procedure, the console made a very loud bang and burning smell was noted.The console displayed error e235 (no lps current).Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

• Brand Name: GREENLIGHT XPS
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS; innovation ctr, silicon valley; 3070 orchard drive; san jose CA 95134 2011
• Manufacturer (Section G): LUMENIS LTD.; yokneam ind. park; hakidma 6; yokneam MA 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22080686
• Report Number: 2124215-2025-33034
• Device Sequence Number: 9338041
• Product Code: GEX
• UDI-Device Identifier: 00878953005508
• UDI-Public: (01)00878953005508
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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: 0010-0210
• Device Catalogue Number: 0010-0210
• Device Lot Number: XPS60136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown