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

Model Number	0010-2090
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a photoselective vaporization of the prostate procedure, when the procedure was started green light appeared in the out-core of the fiber line.There was no effect on the tissue, and there was no laser output from the fiber tip.The fiber was replaced, and the procedure was completed using a new fiber.There were no patient complications.
Additional Manufacturer Narrative
During a photoselective vaporization of the prostate procedure, green light appeared in the out core of the fiber when the procedure began, but there was no tissue effect and no laser output from the fiber tip; the fiber was replaced and the procedure was successfully completed with no patient complications.The device was not returned, and therefore no product analysis could be performed; the prr results did not identify a probable cause.Review of the device history record confirmed that the device met all specifications prior to shipment and no manufacturing deviations were identified.A risk review confirmed that the event type break is included in the product risk documentation and accounted for in the overall risk benefit analysis.A labeling review verified that the ifu warns that accumulation of excessive tissue or debris on the fiber cap can result in overheating and premature degradation or fiber failure.Because the device was not returned, the reported complaint could not be confirmed, and record reviews did not provide additional information or evidence of a probable cause.As a result, the investigation findings neither clearly confirm nor rule out the reported problem, and unable to exclude device problem is identified as the most probable cause.
Event or Problem Description
It was reported that, during a photoselective vaporization of the prostate procedure, when the procedure was started green light appeared in the out core of the fiber line.There was no effect on the tissue, and there was no laser output from the fiber tip.The fiber was replaced, and the procedure was completed using a new fiber.There were no patient complications.

• Brand Name: GREENLIGHT HPS
• 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; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24372975
• Report Number: 2124215-2026-08979
• Device Sequence Number: 17352829
• Product Code: GEX
• UDI-Device Identifier: 00878953004709
• UDI-Public: (01)00878953004709(17)270514(10)36511894
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K062719
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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: 0010-2090
• Device Catalogue Number: 0010-2090
• Device Lot Number: 0036511894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/16/2026
• Date Device Manufactured: 05/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown