MAUDE Adverse Event Report: QUANTA SYSTEM S.P.A. EMPOWER H65; SURGICAL LASER

Model Number	EMP-H65
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The problem could be traced to a component failure.We are unaware about operator/patient injury.We are waiting for additional information from the distributor.
Event or Problem Description
The laser system had a failure that did not allow to use it properly.No adverse effects to patient were reported.
Additional Manufacturer Narrative
The problem could be traced to a component failure.We are unaware about operator/patient injury.We are waiting for additional information from the distributor.
Event or Problem Description
The laser system had a failure that did not allow to use it properly.No adverse effects to patient were reported.

• Brand Name: EMPOWER H65
• Common Device Name: 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: 13304087
• Report Number: 3004378299-2021-00312
• Device Sequence Number: 12006506
• Product Code: GEX
• UDI-Device Identifier: 08033945938901
• UDI-Public: 08033945938901
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: EMP-H65
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown