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

Model Number	0010-0210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Hemorrhage/Blood Loss/Bleeding (1888); Urinary Tract Infection (2120)
Date of Event	04/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During the 112th annual meeting of the japanese urological association journal, a paper was presented with the objective of studying the efficacy and safety of the photoselective vaporization of the prostate (pvp) procedure for treating benign prostatic hyperplasia (bph) in patients with a prostatic volume greater than 80 ml.The study included 151 patients who underwent pvp procedures using a greenlight console between july 2019 and august 2023.Among them, 35 patients with a prostate volume of 80 ml or more were included for comparison.The study evaluated ipss, qol index, urodynamic parameters, changes in residual urine volume, and safety outcomes.In the group of 35 patients, febrile urinary tract infections were observed in 6 patients, posterior hemorrhage requiring tu-ec (transurethral electrocoagulation) occurred in one patient, and one patient required revision surgery.No adverse events were mentioned regarding the group of patients with a prostate volume with less than 80 ml.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.Based on the nature of the information provided to bsc, it is not possible to perform a good faith effort to obtain additional information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.Based on the nature of the information provided to bsc, it is not possible to perform a good faith effort to obtain additional information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
During the 112th annual meeting of the japanese urological association journal, a paper was presented with the objective of studying the efficacy and safety of the photoselective vaporization of the prostate (pvp) procedure for treating benign prostatic hyperplasia (bph) in patients with a prostatic volume greater than 80 ml.The study included 151 patients who underwent pvp procedures using a greenlight console between july 2019 and august 2023.Among them, 35 patients with a prostate volume of 80 ml or more were included for comparison.The study evaluated ipss, qol index, urodynamic parameters, changes in residual urine volume, and safety outcomes.In the group of 35 patients, febrile urinary tract infections were observed in 6 patients, posterior hemorrhage requiring tu-ec (transurethral electrocoagulation) occurred in one patient, and one patient required revision surgery.No adverse events were mentioned regarding the group of patients with a prostate volume with less than 80 ml.

• Brand Name: GREENLIGHT XPS
• 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: 22037744
• Report Number: 2124215-2025-30483
• Device Sequence Number: 15557301
• Product Code: GEX
• UDI-Device Identifier: 00878953005508
• UDI-Public: (01)00878953005508
• 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,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 0010-0210
• Device Catalogue Number: 0010-0210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 06/23/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Sex: Unknown