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

Model Number	0010-0210R
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had been given general anesthesia prior to a photoselective vaporization of the prostate procedure.During the procedure an error message was received stating the fiber port overheated.The fiber was replaced, but the error message appeared with the second fiber also.The procedure was then rescheduled.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.
Additional Manufacturer Narrative
The console was not returned for analysis; however, this console was serviced at the customer's facility by a distributor.The distributor replaced the resonator, and the reported error was cleared confirming the reported event.The laser was then calibrated and passed full functional and electrical safety testing.The resonator was returned and upon receipt at our quality assurance laboratory it was thoroughly analyzed.Functional testing of the resonator found that there was low power output, the resonator had communication issues, the fiber focus lens was dirty, and there were a couple of burnt optics.Based on the information available, and resonator analysis results, the investigation is assigned a conclusion code of cause traced to component failure.
Event or Problem Description
It was reported that the patient had been given general anesthesia prior to a photo selective vaporization of the prostate procedure.During the procedure an error message was received stating the fiber port overheated.The fiber was replaced, but the error message appeared with the second fiber also.The procedure was then rescheduled.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.

• 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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 14989158
• Report Number: 2124215-2022-25233
• Device Sequence Number: 16534879
• Product Code: GEX
• UDI-Device Identifier: 00878953001906
• UDI-Public: 00878953001906
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2022

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: XPS50390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 12/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown