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	02/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a photoselective vaporization of the prostate procedure, after using 10358 joules, and 2 minutes and 8 seconds of fiber use, there was a metal tip rupture.The procedure was completed using another fiber.There were no patient complications reported.
Additional Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.Therefore, the reported allegation of metal tip rupture could not be confirmed.However, the instructions for use (ifu) were reviewed.The ifu state: do not bury the tip in tissue.Do not retract or probe tissue with the device.It is likely that the fiber overheated when it was buried in tissue, causing the alleged metal tip rupture.
Event or Problem Description
It was reported that during a photoselective vaporization of the prostate procedure, after using 10358 joules, and 2 minutes and 8 seconds of fiber use, there was a metal tip rupture.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.The fiber data card was reviewed; it indicated that the fiber was not expired, was recognized and was not fired.However, upon microscope inspection it was identified that the glass tip was detached and it was not returned.The instruction for use (ifu) was reviewed.The ifu states: to avoid greenlight fiber damage or breakage: 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 likely that the glass tip became detached while removing the fiber from its packaging or while advancing the fiber into the scope.Please note that the returned fiber is not manufactured with a metal tip.The tip of the fiber has glass components only.Therefore, the reported metal tip rapture was not confirmed.
Event or Problem Description
It was reported that during a photoselective vaporization of the prostate procedure, after using 10358 joules, and 2 minutes and 8 seconds of fiber use, there was a metal tip rupture.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: 22688482
• Report Number: 2124215-2025-53344
• Device Sequence Number: 14994570
• Product Code: GEX
• UDI-Device Identifier: 00878953004709
• UDI-Public: (01)00878953004709(17)251119(10)32889068
• 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: 11/19/2025
• Device Model Number: 0010-2090
• Device Catalogue Number: 0010-2090
• Device Lot Number: 0032889068
• 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: 07/11/2025
• Supplement Date Received by Manufacturer: 08/07/2025; 10/23/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 09/02/2025; 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• 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