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

Model Number	0010-0210S-G0
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, after the patient was already sedated, there was a fiber connection error that occurred.The fiber was replaced and the unit restarted but it did not resolve the problem.The procedure was not completed due to this issue.This event is being reported for aborted/cancelled procedure with or unknown sedation.
Additional Manufacturer Narrative
B3 date of event: the exact event date is unknown.
Additional Manufacturer Narrative
B3 date of event: the exact event date is unknown.As of today, the above referenced laser console has not been returned; therefore, no physical or visual analysis of the laser console could be performed.However, the console was serviced onsite by a field service engineer (fse).Analysis of the console did not confirm the reported fiber connection error.The fse examined the console and concluded that a possible cause that may have contributed to the reported event could be due to dirt or coating on the connection terminal on the fiber port.He cleaned the fiber port.During testing, the fiber was able to be recognized smoothly.The laser console passed full functional and electrical safety testing, and is working as intended.Based on the information available, a conclusion code of unintended use error caused or contributed to event was assigned to this investigation.
Event or Problem Description
It was reported that during a procedure, after the patient was already sedated, there was a fiber connection error that occurred.The fiber was replaced and the unit restarted but it did not resolve the problem.The procedure was not completed due to this issue.This event is being reported for aborted/cancelled procedure with or unknown sedation.

• 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): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17145409
• Report Number: 2124215-2023-31109
• Device Sequence Number: 12216991
• Product Code: GEX
• UDI-Device Identifier: 08714729979135
• UDI-Public: 08714729979135
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2023

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: 0010-0210S-G0
• Device Catalogue Number: 0010-0210S-G0
• Device Lot Number: XPS61005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown