MAUDE Adverse Event Report: QUANTA SYSTEM S.P.A. LITHO 150; SURGICAL LASER

Model Number	PVMS00062
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Following a detailed clinical investigation into the two reported procedures, it has been established that specific patient-related factors significantly influenced the clinical outcomes.Notably, one of the patients presented with severe prostatic hyperplasia, featuring an estimated volume of 250 cc.Such extreme anatomical dimensions represent a critical confounding factor that increased surgical complexity and inherently elevated the documented risk of post-operative bleeding, which is a known side effect of these interventions.Despite these challenges, no serious clinical consequences occurred in either case, and physiological parameters were successfully restored without the need for blood transfusions.The company is actively monitoring similar events through its post-market surveillance (pms) and is collecting further clinical data regarding the use of litho 150 device in magneto mode, including high-volume procedures, to refine its safety profile.Based on current evidence, these episodes do not represent a significant deviation from established safety analyses, and the benefit-risk ratio remains favorable.We are currently awaiting further technical investigation results from the distributor regarding fiber lot a253165 to complete the final causality assessment.
Event or Problem Description
This report concerns two cases of delayed postoperative hemorrhage following holep (holmium laser enucleation of the prostate) procedures, notified by distributor on 03/05/2026.Both patients required emergency readmission on the first postoperative night due to gross hematuria and obstructive clot formation.In both instances, surgical intervention using a bipolar roller ball was necessary to manage the bleeding and evacuate the clots.

• Brand Name: LITHO 150
• Common Device Name: SURGICAL LASER
• Manufacturer (Section D): QUANTA SYSTEM S.P.A.; via acquedotto, 109; samarate, 21017 ; IT 21017
• Manufacturer (Section G): QUANTA SYSTEM S.P.A.; via acquedotto, 109; samarate, 21017 ; IT 21017
• Manufacturer Contact: dario bandiera ; via acquedotto, 109; samarate, varese 21017 ; IT 21017
• MDR Report Key: 24574555
• Report Number: 3004378299-2026-00001
• Device Sequence Number: 10474684
• Product Code: GEX
• UDI-Device Identifier: 08059173391738
• UDI-Public: 08059173391738
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K141101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 03/11/2026

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
• Device Model Number: PVMS00062
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown