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

Model Number	0010-2090
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993); Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the photoselective vaporization of the prostate procedure, the fiber tip broke at 28,203 joules and 3:39 minutes of use and then forward fired.The procedure was completed with another device.There were no patient complications.
Event or Problem Description
It was reported that during the photoselective vaporization of the prostate procedure, the fiber tip broke at 28,203 joules and 3:39 minutes of use and then forward fired.The procedure was completed with another device.There were no patient complications.
Event or Problem Description
It was reported that during the photoselective vaporization of the prostate procedure, the fiber tip broke at 28,203 joules and 3:39 minutes of use and then forward fired.The procedure was completed with another device.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.Visual analysis identified that the glass tip was detached and not returned.Additionally, the outer flow tube overlaying the glass tip appeared stretched/damaged and distorted.The reported allegation was confirmed.The fiber was functionally tested with the hene (helium-neon) laser fixture.The testing conducted did not identity additional signs of breakage along the length of the fiber.The connector cone, segments, and tabs were in good condition and secured.The control knob was attached and aligned with the fiber and could rotate the fiber.A device history record (dhr) review indicated that there were no manufacturing issues that could have contributed to the reported event.A labeling review was conducted, and evidence suggested the device was used in accordance with the instructions for use (ifu).The ifu warns: to avoid greenlight fiber damage or breakage, do not bury the tip in tissue, do not retract or probe tissue with the device, and to not bend at sharp angles.The ifu also instructs the user: in the unlikely event of a detached tip, it may be visually located through an appropriate scope and removed using forceps.Based on the investigation, a conclusion code of unintended use error caused or contributed to event.The interaction between the user and device caused or contributed to the 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: 22710055
• Report Number: 2124215-2025-52080
• Device Sequence Number: 21124394
• 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): 11/04/2025

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: 09/03/2025; 11/04/2025
• 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