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

Model Number	0010-2090
Medical Device Problem Codes	Nonstandard Device (1420); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a photoselective vaporization of the prostate the fiber was not recognize.The fiber was replaced.There were no patient complications.Analysis of the returned fiber identified that the fiber tip was broken.
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 fiber passed functional testing for connector function.The hene (helium-neon) functional test found no breaks along the fiber length.Microscope inspection identified that the fiber tip was cracked, which was most likely caused by excessive force being applied to the fiber during use.The fiber card was not return with the fiber; thus, the initial allegation of fiber not being recognized by the console could not be confirmed.Device history record review was completed, and it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.The instructions for use (ifu) was reviewed.The ifu states: do not bury the tip in tissue.Do not retract or probe tissue with the device.Do not bend at sharp angles.There were no issues with the translation, wording or graphics.There was no evidence that the device was not used in accordance with the ifu.A risk review of the greenlight hps hazard analysis was completed and confirmed that the event of laser would not recognize fiber was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on information available, the initial allegation of fiber not being recognized by the console, could not be confirmed.However, analysis of the returned fiber identified that the tip was cracked.It is most likely that excessive for was applied during use causing the observed fiber tip damaged.Therefore, a conclusion code of unable to exclude device problem was assigned for reported fiber not recognized.

• 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: 24717776
• Report Number: 2124215-2026-17011
• Device Sequence Number: 6088381
• Product Code: GEX
• UDI-Device Identifier: 00878953004709
• UDI-Public: (01)00878953004709(17)270325(10)36143715
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2026

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: 0036143715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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