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

Model Number	0010-2090
Medical Device Problem Codes	Nonstandard Device (1420); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2026
Type of Reportable Event	Malfunction
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.Additionally, two fiber cards were returned, and no problems were found with them.However, it was identified that the glass tip was broken and detached, and not returned for analysis.The dhr 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 excessively manipulate or bend the fiber.Do not press the fiber end into the tissue, which will create stress between the fiber and the opening (edge) of the endoscope.Damage to the fiber may result.There was no evidence of device misuse, off label use, or failure to follow instructions.A risk review was completed and confirmed that the event 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.Based on all information available, the report fiber tip damaged was confirmed, as analysis of the returned fiber identified that the glass tip was broken and detached.It is likely that the fiber was pressed into tissue and/or was inadvertently bent against the scope edge during use, thereby causing the tip to break and detach.Therefore, an investigation conclusion code of unintended use error caused or contributed to the event was assigned to this investigation.
Event or Problem Description
It was reported that the fiber tip peeled after 5 minutes of use when the surgeon pulled the fiber back inside the optical handle lumen.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

• 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: 25017877
• Report Number: 2124215-2026-22841
• Device Sequence Number: 13377655
• Product Code: GEX
• UDI-Device Identifier: 00878953004709
• UDI-Public: (01)00878953004709(17)270521(10)36569099
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

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: 0036569099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2025
• 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