MAUDE Adverse Event Report: QUANTA SYSTEM S.P.A. LASERCLAST TM FIBER; SURGICAL LASER

Model Number	FT-248
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During prolonged use, the laser tends to turn off, a problem that frequently occurs during surgical procedures, particularly those involving stone removal.On these occasions, the nurse who touches the display receives a slight electric shock.This incident has happened between five and ten times.When it occurs, the display turns black, but the laser remains on.The staff then turns off the laser by pressing the off button and turning the key.After this, they turn the laser back on according to the specified procedure, and the device resumes functioning correctly.
Additional Manufacturer Narrative
The manufacturer is in contact with the customer to obtain more information about the incident.The return of the laser unit to quanta system has been requested so that an investigation can be carried out to understand the cause of the unit's malfunction.
Additional Manufacturer Narrative
Following the notification of this complaint, the manufacturer requested the return of the device to conduct technical investigations into the described problem.Various tests were performed on the device, but we could not replicate the reported issue.The device fully complies with the defined operating parameters, as confirmed by the attached report.Additionally, there have been no updates indicating any worsening of the health conditions of the operators, nor any need for additional procedures to recover vital functions.Therefore, we do not consider this complaint to meet the requirements for reportability.Since we do not have any electrical system verification tests of the reporter's facility, at the conclusion of the technical investigation report.It was recommeded to check the main line and its grounding at the installation site and to repeat the safety test.
Event or Problem Description
During prolonged use, the laser tends to turn off, a problem that frequently occurs during surgical procedures, particularly those involving stone removal.On these occasions, the nurse who touches the display receives a slight electric shock.This incident has happened between five and ten times.When it occurs, the display turns black, but the laser remains on.The staff then turns off the laser by pressing the off button and turning the key.After this, they turn the laser back on according to the specified procedure, and the device resumes functioning correctly.

• Brand Name: LASERCLAST TM FIBER
• 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: 21492771
• Report Number: 3004378299-2025-00002
• Device Sequence Number: 11761180
• Product Code: GEX
• UDI-Device Identifier: 08059173392285
• UDI-Public: 08059173392285
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K210142
• 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: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

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
• Device Model Number: FT-248
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 02/28/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2022
• 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
• Patient Sex: Unknown