MAUDE Adverse Event Report: QUANTA SYSTEM S.P.A. LITHO 60; SURGICAL LASER

Model Number PVMS00049

Device Problem Protective Measures Problem (3015)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The problem is under investigation and can be traced to a component failure.We are unaware about operator injury.We are waiting for additional information from distributor.

Event Description

The laser system had a failure that did not allow to use it properly.No adverse effects to patient were reported.

Manufacturer Narrative

The problem can be traced to a component failure.We are unaware about operator injury.

Event Description

The laser system had a failure that did not allow to use it properly.No adverse effects to patient were reported.

• Brand Name: LITHO 60
• Type of Device: SURGICAL LASER
• Manufacturer (Section D): QUANTA SYSTEM S.P.A.; via acquedotto, 109; samarate, 21017 ; IT 21017
• MDR Report Key: 8981167
• MDR Text Key: 175849849
• Report Number: 3004378299-2019-00144
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 08033945937492
• UDI-Public: 08033945937492
• Combination Product (y/n): N
• PMA/PMN Number: K172025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PVMS00049
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1