MAUDE Adverse Event Report: QUANTA SYSTEM, S.P.A. OPTIC LASER FIBER; POWERED LASER SURGICAL INSTRUMENT

Catalog Number	OAF703611
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During cystoscopy/ureteroscopy and holmium lase, optic fiber fractured while inside patient.Patient had multiple large stones.All pieces of the fiber were removed from the patient, no injury noted.

• Brand Name: OPTIC LASER FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): QUANTA SYSTEM, S.P.A.; samarate, va, varese ; IT
• MDR Report Key: 21874420
• Report Number: MW5169350
• Device Sequence Number: 8097983
• Product Code: GEX
• UDI-Device Identifier: 08033945938529
• UDI-Public: 08033945938529
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/16/2025

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 Catalogue Number: OAF703611
• Device Lot Number: A244904
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: White