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

Model Number	0010-0210R
Medical Device Problem Codes	Fluid/Blood Leak (1250); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the nurse was adding water to the laser console, the water began to leak, and smoke began to come out of the system.There was no patient or procedure involved in this event.
Additional Manufacturer Narrative
Boston scientific concludes that the reported performance allegation in this complaint has not been confirmed, as the product was not returned for analysis.Without a returned device, no physical or visual analysis of the product could be performed.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that when the nurse was adding water to the laser console, the water began to leak, and smoke began to come out of the system.There was no patient or procedure involved in this event.
Event or Problem Description
It was reported that there was added water to the laser, the water started to leak, and smoke started coming out of the system.There was no patient involvement.
Additional Manufacturer Narrative
The laser console was returned for repairs and during the inspection the console showed significant damage to the bottom half of the chassis.Additionally, the autovolt board, isolation transformer and other sub-assemblies were fried.Due to the amount of damage, the exact location of where the leak came from could not be determined.The water leak was large enough to cause the sub-assemblies to short and fry.Thus, resulted in the smoke.Due to the amount of damage, it was decided it was not worth repairing so it will be scrapped out.Due to this, the reported fluid leak and smoking complaints were confirmed.A dhr (device history record) / shr (service history record) review found the laser console was installed on 07 september 2018.This laser console was covered under a semi-annual preventive maintenance service contract.The laser console was fully functional from that date until the report complaint date of 03 april 2024.A labeling review found that there was no evidence that the console was used in a manner inconsistent with the labeling.While the laser console was damaged by a water leak, what caused the water leak was could not be determined.Thus, it can be concluded that unknown factors most probably contributed to the reported event.Based on review of all information available and analysis results, a conclusion code of cause not established was assigned to this investigation.

• Brand Name: GREENLIGHT XPS LASER SYSTEM
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS; 3070 orchard drive; san jose CA 95134 2011
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19176647
• Report Number: 2124215-2024-24747
• Device Sequence Number: 3851450
• Product Code: GEX
• UDI-Device Identifier: 00878953001906
• UDI-Public: 00878953001906
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K092735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2024

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: 0010-0210R
• Device Catalogue Number: 0010-0210R
• Device Lot Number: XPS50441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 05/17/2024; 09/11/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 06/09/2024; 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown