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

Model Number	0010-2090
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a photoselective vaporization of the prostate, after using 7494 joules and 1 minute and 46 seconds of fiber use, forward firing occurred.The procedure was completed using another fiber.There were no patient complications reported.
Event or Problem Description
It was reported that during a photoselective vaporization of the prostate, after using (b)(4) joules and 1 minute and 46 seconds of fiber use, forward firing occurred.The procedure was completed using another fiber.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this fiber was thoroughly analyzed.Visual inspection did not find visible defects on the fiber body.The hene (helium-neon) functional test found no breaks along the fiber length.The fiber passed the functional test for the connector function.However, upon microscope inspection it was identified that the glass tip was detached and it was not returned.Therefore, the reported event was confirmed.A detached tip would cause the fiber energy to fire forward from the tip.The instruction for use (ifu) was reviewed.The ifu states: to avoid greenlight fiber damage or breakage: do not bury the tip in tissue.Do not retract or probe tissue with the device.Do not bend at sharp angles.In the unlikely event of a detached tip, it may be visually located through an appropriate scope and removed using forceps.Device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.It is most likely that the interaction between the user and device, or sample, caused or contributed to the error.
Event or Problem Description
It was reported that during a photoselective vaporization of the prostate, after using 7494 joules and 1 minute and 46 seconds of fiber use, forward firing occurred.The procedure was completed using another fiber.There were no patient complications reported.

• 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: 22806472
• Report Number: 2124215-2025-56644
• Device Sequence Number: 20783009
• Product Code: GEX
• UDI-Device Identifier: 00878953004709
• UDI-Public: (01)00878953004709(17)260326(10)33704575
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 11/19/2025

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 Expiration Date: 03/26/2026
• Device Model Number: 0010-2090
• Device Catalogue Number: 0010-2090
• Device Lot Number: 0033704575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 08/19/2025; 10/23/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 09/17/2025; 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2024
• 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