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

Model Number PVMS00049

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2022

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

The problem consists of low energy error appearing on the screen.We are unaware about operator/patient injury.

• Brand Name: LITHO 60
• Type of Device: 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: 13665484
• MDR Text Key: 286557329
• Report Number: 3004378299-2022-00025
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 08033945937492
• UDI-Public: 08033945937492
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192600
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PVMS00049
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/30/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1