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 29688 joules and 11 minutes and 6 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 29688 joules and 11 minutes and 6 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 tests for connector function.Microscopic inspection identified that the fiber tip was detached.It is likely that the damaged occurred when excessive force was inadvertently applied to the fiber as it was removed from the package, as it was inserted into the scope, as it was being used during the case, or any combination of thereof.Therefore, the reported fiber tip break was confirmed.The device instructions for use (ifu) was reviewed.The ifu states: connect the tubing from the sterile saline for irrigation solution to the fiber luer lock connector.Position the saline solution at least 106 cm higher than the level of the endoscope/cystoscope.Increased irrigation flow by means of a saline pressure bag (set to 250 mmhg - 300 mmhg) will further increase liquid cooling effect and may reduce fiber tip damage.Caution: do not bury the tip of the fiber into the tissue.Reduced irrigation fluid flow may result in damage to the fiber.Accumulation of debris may result in over heating of the fiber cap leading to premature fiber degradation or fiber failure.Ensure that distance from the fiber to the tissue is approximately 2 mm (1 to 3 mm).The interaction between the user and device, most likely caused or contributed to the observed fiber tip damage.
Event or Problem Description
It was reported that during a photoselective vaporization of the prostate procedure, after using 29688 joules and 11 minutes and 6 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: 22708486
• Report Number: 2124215-2025-53351
• Device Sequence Number: 21171598
• 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): 11/07/2025

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; 10/14/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 09/02/2025; 11/07/2025
• 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