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	07/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fiber tip broke.There were no patient complications.
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 device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Based on the information available, the cause that contributed to the reported event cannot be established.A risk review was completed and confirmed that the event of "fiber cap/tip-break" was defined in the risk documentation and is documented accordingly.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.There is no objective evidence that the user did not properly handle or use the device according to the instructions for use (ifu).The ifu states: do not use if the fiber appears damaged.If damaged, replace the fiber with a new one.Use of a damaged fiber may result in injury to the patient or injury to the user.Based on all the information available, a conclusion code of cause not established was assigned to this investigation, as it was unable to determine a probable cause for the complaint.

• 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: 50255914
• Report Number: 2124215-2026-43719
• Device Sequence Number: 13227246
• Product Code: GEX
• UDI-Device Identifier: 00878953004709
• UDI-Public: (01)00878953004709(17)280304(10)38753724
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K062719
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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: 0038753724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 03/05/2026
• 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