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

Catalog Number PVMS00033

Device Problem Protective Measures Problem (3015)

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

Event Date 12/22/2018

Event Type  malfunction  

Manufacturer Narrative

The problem was due to a component failure.We are unaware about patient injury.

Event Description

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

• Brand Name: LITHO
• Type of Device: SURGICAL LASER
• Manufacturer (Section D): QUANTA SYSTEM S.P.A.; via acquedotto, 109; samarate, varese 21017 ; IT 21017
• Manufacturer (Section G): QUANTA SYSTEM S.P.A.; via acquedotto, 109; samarate, varese 21017 ; IT 21017
• Manufacturer Contact: francesco dell'antonio ; via acquedotto, 109; samarate, varese 21017 ; IT 21017
• MDR Report Key: 8269907
• MDR Text Key: 133832261
• Report Number: 3004378299-2018-00164
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K141101
• 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: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: PVMS00033
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/24/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2018
• 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