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

Model Number	PVMS00052
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2020
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 information from the ditributor.
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: 10283307
• Report Number: 3004378299-2020-00101
• Device Sequence Number: 2853826
• Product Code: GEX
• UDI-Device Identifier: 08033945938185
• UDI-Public: 08033945938185
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 07/16/2020

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1