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

Model Number CYBER TM150

Device Problems Device Operates Differently Than Expected (2913); Issue With Displayed Error Message (2967)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2016

Event Type  malfunction  

Manufacturer Narrative

The problem was due to a component failure (not working chiller 2).We are unaware about patient injury.

Event Description

The laser system has the following problem: " cyber shut down with no notice and after restarting unit no resolution of the problem was found.After unit check, flow sensor 1 error found ".No adverse effects to patient were reported.

• Brand Name: QUANTA SYSTEM S.P.A.
• Type of Device: SURGICAL LASER
• Manufacturer (Section D): QUANTA SYSTEM S.P.A.; via iv novembre, 116; solbiate olona, varese 21058 ; IT 21058
• Manufacturer (Section G): QUANTA SYSTEM S.P.A.; via iv novembre, 116; solbiate olona, varese 21058 ; IT 21058
• Manufacturer Contact: francesco dell'antonio ; via iv novembre, 116; solbiate olona, varese 21058 ; IT 21058 ; 9033137679
• MDR Report Key: 5519587
• MDR Text Key: 41248063
• Report Number: 3004378299-2016-00017
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102749
• 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: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CYBER TM150
• Device Catalogue Number: PUMS00004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2012
• 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