MAUDE Adverse Event Report: QUANTA SYSTEMS S.P.A. QUANTA LITHO 150 WATT HOLMIUM LASER

Model Number	G58931
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Complainant reported they believe the laser was not functioning properly and patient was readmitted over the weekend for bleeding following holep procedure.Complainant believes laser may be the cause.

• Brand Name: QUANTA LITHO 150 WATT HOLMIUM LASER
• Common Device Name: HOLMIUM LASER
• Manufacturer (Section D): QUANTA SYSTEMS S.P.A.; via acquedoto, 109; samarate ; IT
• MDR Report Key: 24680128
• Report Number: 3016054554-2026-00001
• Device Sequence Number: 21264062
• Product Code: GEX
• UDI-Device Identifier: 08059173391738
• UDI-Public: 08059173391738
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2026
• Report Date (Section F): 03/24/2026

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: G58931
• Device Catalogue Number: LITHO-150
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/16/2026
• Date Report to Manufacturer: 03/18/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2026
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/24/2026