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

Model Number CYBER TM

Device Problems Output below Specifications (3004); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2014

Event Type  malfunction  

Manufacturer Narrative

We are waiting for additional information.We are unaware about pt injury.

Event Description

The laser system has the following problem: "low power output".No adverse effects to pt were reported, the problem happened during maintenance.

• 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: maurizio bianchi ; via iv novembre,116; solbiate olona, varese 21058 ; IT 21058 ; 9033137679
• MDR Report Key: 5744402
• MDR Text Key: 48101983
• Report Number: 3004378299-2014-00114
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CYBER TM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2014
• 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