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

Model Number	PVMS00046
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The problem was due to a component failure.We are unaware about patient injury.We are waiting for additional information from the distributor.
Event or Problem Description
The laser system had a failure that did not allow to use it.No adverse effects to patient were reported.
Additional Manufacturer Narrative
The problem was related to a transitory/random error; it was not possible to recreate such error.We are unaware about patient injury.
Event or Problem Description
The laser system had a failure that did not allow to use it.No adverse effects to patient were reported.

• Brand Name: LITHO
• Common Device Name: SURGICAL LASER
• Manufacturer (Section D): QUANTA SYSTEM S.P.A.; via acquedotto, 109; samarate, varese 21017 ; IT 21017
• MDR Report Key: 8023162
• Report Number: 3004378299-2018-00108
• Device Sequence Number: 16489016
• Product Code: GEX
• UDI-Device Identifier: 08033945936785
• UDI-Public: 08033945936785
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K163009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2020

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: PVMS00046
• Device Catalogue Number: PVMS00046
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2018
• Supplement Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1