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

Model Number	PVMS00052
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The problem is under investigation and could be traced to a component failure.We are unaware about operator injury.We are waiting for additional information from 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
Device forced to standby status during operation due to loss of calibration.Problem has been fixed.No adverse events have been 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.

• 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: 9860786
• Report Number: 3004378299-2020-00031
• Device Sequence Number: 3374747
• Product Code: GEX
• UDI-Device Identifier: 08033945938185
• UDI-Public: 08033945938185
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 09/18/2020

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: PVMS00052
• Device Catalogue Number: EMP-H35
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/20/2020
• 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