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	12/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the photoselective vaporization of the prostate procedure, when the procedure was started green light was observed in the outcore of the fiber line, but there was no effect on the tissue.No energy was emitted from the fiber tip while the physician was attempting vaporization.As a result, the fiber was replaced with a new one to complete the procedure.There were no patient complications.
Additional Manufacturer Narrative
During a photoselective vaporization of the prostate procedure, green light was observed in the out core of the fiber when the procedure began, but no tissue effect occurred because no energy was emitted from the fiber tip while the physician attempted vaporization; the fiber was replaced and the procedure was completed without patient complications.The device was not returned; therefore, no product analysis could be performed, although the customer provided video confirmed the complaint and showed that the fiber was engaged.Review of the device history record confirmed the device met specifications prior to shipment and showed no manufacturing deviations.The risk documentation includes the event type break, and it is accounted for within the product risk analysis.Labeling review confirmed that the ifu warns that accumulation of tissue or debris on the laser fiber cap may cause overheating and lead to premature degradation or fiber failure.Prr results did not identify a probable cause.Without device return, the root cause could not be determined; therefore, the event is considered linked to the device but cannot be traced more specifically.No patient complications were reported, and no escalation is required.
Event or Problem Description
It was reported that during the photoselective vaporization of the prostate procedure, when the procedure was started green light was observed in the outcore of the fiber line, but there was no effect on the tissue.No energy was emitted from the fiber tip while the physician was attempting vaporization.As a result, the fiber was replaced with a new one to complete the procedure.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: 24300372
• Report Number: 2124215-2026-07322
• Device Sequence Number: 9652492
• 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: Foreign
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 02/09/2026
• 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