MAUDE Adverse Event Report: QUANTA SYSTEM S.P.A. CYBER TM 200; SURGICAL LASER

Model Number PUMS00007

Device Problem Temperature Problem (3022)

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

Event Date 05/04/2021

Event Type  malfunction  

Manufacturer Narrative

The problem may could be traced to component failure.We are unaware about operator injury.We are waiting for more information.

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: CYBER TM 200
• 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: sergio zanzottera ; via acquedotto, 109; samarate, varese 21017 ; IT 21017
• MDR Report Key: 12113811
• MDR Text Key: 260665424
• Report Number: 3004378299-2021-00133
• 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
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 07/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PUMS00007
• Date Manufacturer Received: 06/03/2021
• 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