MAUDE Adverse Event Report: QUANTA SYSTEM S.P.A. LITHO 100; SURGICAL LASER

Model Number	PVMS00055
Medical Device Problem Codes	Calibration Problem (2890); Optical Problem (3001); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The problem could be traced to component failure.We are unaware about operator injury.
Event or Problem Description
The laser system had a failure that did not allow to use it properly.No adverse effects to patient were reported.
Event or Problem Description
The laser system had a failure that did not allow to use it properly.No adverse effects to patient were reported.
Additional Manufacturer Narrative
The problem is traced to component failure.We are unaware about operator injury.

• Brand Name: LITHO 100
• Common Device Name: SURGICAL LASER
• Manufacturer (Section D): QUANTA SYSTEM S.P.A.; via acquedotto, 109; samarate, 21017 ; IT 21017
• MDR Report Key: 12381411
• Report Number: 3004378299-2021-00195
• Device Sequence Number: 11709894
• Product Code: GEX
• UDI-Device Identifier: 08033945938369
• UDI-Public: 08033945938369
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K192600
• 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,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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: No Information
• Device Model Number: PVMS00055
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 08/29/2021
• Supplement Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1