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

Model Number	0010-2090
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blockb3: the exact event date is unknown.The provided event date 05/01/2025 was used as the best estimate based on the date the manufacturer became aware of the event, 05/28/2025.
Event or Problem Description
It was reported that the procedure was interrupted due to machine trouble during the procedure.As it was possible that the problem was with the hps fiber, the problem was not resolved even after replacing it with another lot.The procedure was not completed.The patient sedation status was not reported.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia or whose sedation status was unknown.
Additional Manufacturer Narrative
This report is being submitted to correct the impact codes field (h6) in section h, device manufacturers only.Blockb3: the exact event date is unknown.The provided event date 05/01/2025 was used as the best estimate based on the date the manufacturer became aware of the event, 05/28/2025.
Event or Problem Description
It was reported that the procedure was interrupted due to machine trouble during the procedure.As it was possible that the problem was with the hps fiber, the problem was not resolved even after replacing it with another lot.The procedure was not completed.The patient sedation status was not reported.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia or whose sedation status was unknown.

• 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; taman perindustrial batu kawan; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22328081
• Report Number: 2124215-2025-41078
• Device Sequence Number: 18245413
• Product Code: GEX
• UDI-Device Identifier: 00878953004709
• UDI-Public: (01)00878953004709(17)250801(10)32134253
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 08/06/2025

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: 08/01/2025
• Device Model Number: 0010-2090
• Device Catalogue Number: 0010-2090
• Device Lot Number: 0032134253
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 08/06/2025
• Date Device Manufactured: 08/02/2023
• 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