MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS GREENLIGHT XPS LASER SYSTEM; POWERED LASER SURGICAL INSTRUMENT

Model Number	0010-0210
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a photoselective vaporization of the prostate procedure, error 832 (int 0 test failed) and 302 (mcb hardware interlock bit) were displayed.The procedure was not completed due to this error code.There was no patient outcome reported.
Additional Manufacturer Narrative
E1 initial reporter: new information updated this field.E3 occupation: new information updated this field.G2 report source: new information updated this field.The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.It was initially reported the procedure was not completed.Additional information received clarified that the procedure was completed using a different method and there were no patient complications.Based on the information available, the conclusion code is not yet available as the investigation has not been completed at this time.The manufacturer has reviewed all information and determined that since the procedure was not aborted, this event no longer meets reporting criteria for the device in question.
Event or Problem Description
It was reported that, during a photoelectric vaporization of the prostate procedure, error 832 (int 0 test failed) and 302 (mcb hardware interlock bit) were displayed.The procedure was completed via a different method without patient complications.

• Brand Name: GREENLIGHT XPS LASER SYSTEM
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS; innovation ctr, silicon valley; 3070 orchard drive; san jose CA 95134 2011
• 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: 20561789
• Report Number: 2124215-2024-67867
• Device Sequence Number: 3250597
• Product Code: GEX
• UDI-Device Identifier: 00878953005508
• UDI-Public: 00878953005508
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2024

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: 0010-0210
• Device Catalogue Number: 0010-0210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/24/2024
• Date Device Manufactured: 08/01/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown