MAUDE Adverse Event Report: QUANTA SYSTEM S.P.A. EMPOWER H100; SURGICAL LASER

Model Number	PVMS00053
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The problem was due 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.
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 due to a component failure, but it was not possible to determine the root cause due to missing information.We are unaware about operator injury.

• Brand Name: EMPOWER H100
• Common Device Name: SURGICAL LASER
• Manufacturer (Section D): QUANTA SYSTEM S.P.A.; via acquedotto, 109; samarate, 21017 ; IT 21017
• MDR Report Key: 8964868
• Report Number: 3004378299-2019-00143
• Device Sequence Number: 14064645
• Product Code: GEX
• UDI-Device Identifier: 08033945938208
• UDI-Public: 08033945938208
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K180922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

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: PVMS00053
• Device Catalogue Number: EMP-H100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1