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

Model Number	0010-0210Z
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation for a photoselective vaporization of the prostate procedure, error 171 occurred.The procedure was not completed.There was no patient complication related to this event.This event is being reported for procedure/post sedation and where the procedure was cancelled.

• 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
• MDR Report Key: 12224515
• Report Number: 2124215-2021-21017
• Device Sequence Number: 12044114
• Product Code: GEX
• UDI-Device Identifier: 00878953001913
• UDI-Public: 00878953001913
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/26/2021

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: 08/31/2025
• Device Model Number: 0010-0210Z
• Device Catalogue Number: 0010-0210Z
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 07/26/2021
• Patient Sequence Number: 1