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

Model Number	0010-2090
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
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 the functional test for the connector.The hene (helium-neon) test found no breaks along the fiber length.The fiber passed the fiber card data review, the fiber was not expired, was recognized, and was fired.Microscopic inspection identified that the glass tip was cracked.It is likely that the user inadvertently cracked the fiber while attempting to reposition it during use, or during advancement of the fiber inside the scope.Also, the outer flow tubing appeared to be melted.Melting of the outer flow tubing likely occurred when the fiber overheated during use.The instruction for use (ifu) states: do not bury the tip in tissue.Do not retract or probe tissue with the device.Do not bend at sharp angles.If excessive tissue or debris is allowed to accumulate on the laser fiber cap, overheating of the laser fiber cap will occur leading to premature laser fiber degradation and/or laser fiber failure.With all the available information, boston scientific concludes the interaction between the user and device, or sample, most likely caused or contributed to the observed glass tip cracked and melted outer flow tubing, as there was no evidence of design or manufacturing issue that could have contributed to the observed condition of the fiber.
Event or Problem Description
It was reported that the fiber was returned with not existing complaint.Laboratory analysis of the returned identified that the glass cap was cracked and the outer flow tubing appeared to be melted.

• 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: 22650524
• Report Number: 2124215-2025-51426
• Device Sequence Number: 8762577
• Product Code: GEX
• UDI-Device Identifier: 00878953004709
• UDI-Public: (01)00878953004709(17)250925(10)32502733
• 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
• Type of Report: Initial
• Report Date (Section B): 07/29/2025

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: 09/25/2025
• Device Model Number: 0010-2090
• Device Catalogue Number: 0010-2090
• Device Lot Number: 0032502733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown