MAUDE Adverse Event Report: QUANTA SYSTEM S.P.A. MULTIDIODE DERMA 1470; SURGICAL LASER

Model Number	PDMS00203
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The problem was due to a component failure.We are unaware about patient injury.We are waiting for additional information from the distributor.
Event or Problem Description
The laser system had a failure that did not allow to use it.No adverse effects to patient were reported.
Event or Problem Description
The laser system had a failure that did not allow to use it.No adverse effects to patient were reported.
Additional Manufacturer Narrative
The problem can be traced to an optical component failure.We are unaware about patient injury.

• Brand Name: MULTIDIODE DERMA 1470
• Common Device Name: SURGICAL LASER
• Manufacturer (Section D): QUANTA SYSTEM S.P.A.; via acquedotto, 109; samarate, varese 21017 ; IT 21017
• MDR Report Key: 7968449
• Report Number: 3004378299-2018-00097
• Device Sequence Number: 11066295
• Product Code: GEX
• UDI-Device Identifier: 08033945934330
• UDI-Public: 08033945934330
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Inspection,Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2020

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: PDMS00203
• Device Catalogue Number: PDMS00203
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1