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	10/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a photoselective vaporization of the prostate procedure, the fiber broke off after using 218810 joules and 10 minutes with 41 seconds of fiber use.It was noted that the fiber break occurred at 0.5 cm from the tip.The fiber piece was retrieved using forceps.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.The instructions for use (ifu) was reviewed.The ifu states: in the unlikely event of a detached tip, it may be visually located through an appropriate scope and removed using forceps.Irrigate the area thoroughly to remove any traces of fiber or other material.If the aim beam or working beam exit the end of the fiber, discontinue use immediately and discard the fiber.Device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.It is likely that the user broke the tip of the fiber upon advancing the fiber into the scope, and/or buried the tip of the fiber into tissue during use.Based on all information available, the interaction between the user and device, most likely caused or contributed to the reported event.
Event or Problem Description
It was reported that during a photoselective vaporization of the prostate procedure, the fiber broke off after using 218810 joules and 10 minutes with 41 seconds of fiber use.It was noted that the fiber break occurred at 0.5 cm from the tip.The fiber piece was retrieved using forceps.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
Event or Problem Description
It was reported that during a photoselective vaporization of the prostate procedure, the fiber broke off after using 218810 joules and 10 minutes with 41 seconds of fiber use.It was noted that the fiber break occurred at 0.5 cm from the tip.The fiber piece was retrieved using forceps.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
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.Data from the fiber card indicated that the fiber was not expired, was recognized and fired.Microscope inspection of the fiber tip identified that the glass tip was broken off and not returned.It is likely that excessive force on the fiber during use along with tissue contact caused the fiber tip to break.A review of the instructions for use (ifu) was completed.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.Device history record (dhr) review was completed, and it was confirmed that the device met all material, assembly and performance specifications.It is probable that the user broke the tip of the fiber upon advancing the fiber into the scope, and/or buried the tip of the fiber into tissue during use.A risk review was completed and confirmed that the event of fiber cap/tip detached/broke inside patient 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 all available information, it is likely that the interaction between the user and device, caused or contributed to the reported event, therefore, an investigation conclusion code of unintended use error caused or contributed to the event was assigned to this investigation.

• 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: 23722434
• Report Number: 2124215-2025-88878
• Device Sequence Number: 8745073
• Product Code: GEX
• UDI-Device Identifier: 00878953004709
• UDI-Public: (01)00878953004709(17)270721(10)37013453
• 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,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2026

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: 0037013453
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 12/09/2025; 02/27/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/02/2026; 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2025
• 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