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	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a photoselective vaporization of the prostate, the fiber tip broke after 13 minutes and 50 seconds of use.The procedure was completed using another fiber.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.A review of the device instructions for use (ifu) was completed.The ifu states: do not bury the tip in tissue.Do not bend at sharp angles.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that during a photoselective vaporization of the prostate, the fiber tip broke after 13 minutes and 50 seconds of use.The procedure was completed using another 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: 24052826
• Report Number: 2124215-2026-02085
• Device Sequence Number: 13267568
• Product Code: GEX
• UDI-Device Identifier: 00878953004709
• UDI-Public: (01)00878953004709(17)270325(10)36143714
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/06/2026

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: 0036143714
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/06/2026
• Date Device Manufactured: 03/25/2025
• 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