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

Model Number	EMP-H65
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The problem could be traced to component failure.We are unaware about operator injury.
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
• MDR Report Key: 12475125
• Report Number: 3004378299-2021-00208
• Device Sequence Number: 3779821
• Product Code: GEX
• UDI-Device Identifier: 08033945938901
• UDI-Public: 08033945938901
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K180423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Repair,Inspection
• Type of Report: Initial
• Report Date (Section B): 09/15/2021

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
• Operator of Device: No Information
• Device Model Number: EMP-H65
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1