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

Model Number	0010-2090
Medical Device Problem Codes	Overheating of Device (1437); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a photo selective vaporization of the prostate procedure for benign prostatic hyperplasia, the fiber was overheated and stopped working after 9:57 minutes and 31034 joules used.The procedure was completed with another device without patient complications.The fiber was returned and the analysis revealed that the glass cap was detached.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.Microscope analysis identified that the fiber glass tip was broken off, and tip did not return.The fiber card indicated that the fiber was recognized by the console and used.A soft joule limit was observed.A soft joule limit is a courtesy message, which, indicates the point at which any fiber removal from the console would invalidate further fiber usage.The fiber was functionally tested with the hene (helium-neon) laser fixture.The testing conducted did not identify signs of breakage along the length of the fiber body.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 to 300 mmhg) will further increase liquid cooling effect and may reduce fiber tip damage.Do not bury the tip of the fiber into the tissue.Reduced irrigation fluid flow may result in damage to the fiber.Ensure the distance from the fiber to the tissue is approximately 2 mm (1 to 3 mm).Accumulation of debris may result in over heating of the fiber cap leading to premature fiber degradation or fiber failure.The observed glass tip break is consistent with fiber that experienced tissue adhesion, constant heavy tissue contact, and/or a decrease in the saline cooling flow, which leads to elevated temperature near the laser beam output window.These factors are likely to cause the noted glass tip detachment/separation.Therefore, the investigation is assigned a conclusion code of unintended use error caused or contributed to event.The interaction between the user and device, caused or contributed to the observed fiber tip damage and reported event.

• 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: 22595815
• Report Number: 2124215-2025-44662
• Device Sequence Number: 9154592
• Product Code: GEX
• UDI-Device Identifier: 00878953004709
• UDI-Public: (01)00878953004709(17)250515(10)31624462
• 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
• Report Date (Section B): 07/24/2025

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: 05/15/2025
• Device Model Number: 0010-2090
• Device Catalogue Number: 0010-2090
• Device Lot Number: 0031624462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2023
• 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