MAUDE Adverse Event Report: QUANTA SYSTEM S.P.A. SINGLE USE SURGICAL OPTICAL FIBER; EMP-FBX550HS

Model Number	EMP-FBX550HS
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During use of the laser system, a flame was observed on the laser fiber near the connection to the laser generator.The event was immediately identified and managed by the clinical staff; laser emission was stopped and the flame was extinguished using a wet towel.The event resulted only in a delay of the treatment and rendered the device unusable.No harm or injury to the patient or staff occurred, no clinical consequences were observed, and the flame did not involve the surgical field.The affected laser fiber will be retrieved and analyzed internally to further investigate the potential causes of the event.
Event or Problem Description
A flame was observed on the laser fiber near the connection to the laser machine.The flame was immediately called out and extinguished with a wet towel.No harm or injury to patient was identified.

• Brand Name: SINGLE USE SURGICAL OPTICAL FIBER
• Common Device Name: EMP-FBX550HS
• 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: 25031045
• Report Number: 3004378299-2026-00003
• Device Sequence Number: 8919516
• Product Code: GEX
• UDI-Device Identifier: 08033945938444
• UDI-Public: 08033945938444
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180158
• 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: Replace,Inspection
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

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
• Device Model Number: EMP-FBX550HS
• Device Lot Number: H244320
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown