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

Model Number	0010-2090
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fiber broke intraoperatively at its distal end after 14 minutes when the surgeon retracted it into the fiber holder.The fiber tip also peeled.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 the fiber broke intraoperatively at its distal end after 14 minutes when the surgeon retracted it into the fiber holder.The fiber tip also peeled.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual analysis identified that the glass tip was detached from the distal end of the fiber, which likely occurred when the tip of the fiber was pushed into tissue during use.Additionally, the outer flow tube was torn from the fiber tip and was likely caused when the glass tip broke.The reported allegation was confirmed.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.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 bury the tip of the fiber into the tissue.Reduced irrigation fluid flow may result in damage to the fiber.Do not retract, dissect, or probe tissue with the tip of the fiber.Damage may occur to the fiber tip.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.Do not bend the fiber at sharp angles.Damage may occur to the fiber.A risk review was completed and confirmed that the event was defined in the risk documentation and was documented in the prr 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, a 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: 24471414
• Report Number: 2124215-2026-11060
• Device Sequence Number: 18545673
• 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,Followup
• Report Date (Section B): 04/27/2026

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: 0036569099
• 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: 02/09/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/27/2026
• 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