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	03/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Complainant reported they believe laser was not functioning properly and determined to pull it out of service until a technician could look at it.Complainant reported they believe the laser caused excessive bleeding during 2 holeps.Attendee believed it was related to a fw updated which had been done the day prior.Procedure was completed as bipolar was used to control bleeding.Patient was admitted overnight.

• Brand Name: QUANTA LITHO 150 WATT HOLMIUM LASER
• Common Device Name: HOLMIUM LASER
• Manufacturer (Section D): QUANTA SYSTEMS S.P.A.; via acquedotto, 109; samarate ; IT
• MDR Report Key: 24680241
• Report Number: 3016054554-2026-00003
• Device Sequence Number: 13263019
• 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): 03/05/2026
• 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?: Yes
• 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: 03/05/2026
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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