MAUDE Adverse Event Report: QUANTA SYSTEM S.P.A. EMPOWER H35; SURGICAL LASER

Model Number	EMP-H35
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The problem may could be traced to a component failure.We are unaware about operator injury.We are waiting for more informations from the distributors.
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.
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 was related to a component failure (blast shield).The device has been repaired.We are unaware about patient injury.

• Brand Name: EMPOWER H35
• Common Device Name: SURGICAL LASER
• Manufacturer (Section D): QUANTA SYSTEM S.P.A.; via acquedotto, 109; samarate, 21017 ; IT 21017
• MDR Report Key: 10101612
• Report Number: 3004378299-2020-00072
• Device Sequence Number: 3448420
• Product Code: GEX
• UDI-Device Identifier: 08033945938895
• UDI-Public: 08033945938895
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K180426
• 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,Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2020

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-H35
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2020
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1