MAUDE Adverse Event Report: QUANTA SYSTEM S.P.A. LIGHT 4V; DERMATOLOGICAL AND AESTHETIC LASER

Model Number	PCMS00319
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Laser system caused trivial burns that will probably heal on patient face due to rod failure.
Event or Problem Description
Laser system caused trivial facial burns that will probably heal.

• Brand Name: LIGHT 4V
• Common Device Name: DERMATOLOGICAL AND AESTHETIC 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: 15475336
• Report Number: 3004378299-2022-00234
• Device Sequence Number: 2873660
• Product Code: GEX
• UDI-Device Identifier: 08033945934149
• UDI-Public: 08033945934149
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K192160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 09/23/2022

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: PCMS00319
• Device Catalogue Number: PCMS00319
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2021
• 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