MAUDE Adverse Event Report: QUANTA SYSTEM S.P.A. OLYMPUS EMPOWER H65; SURGICAL LASER

Model Number EMP-H65

Device Problem Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

The problem may could be traced to component failure.We are unaware about operator injury.We are waiting for more information.

Event Description

The laser system had a failure that did not allow to use it properly.No adverse effects to patient were reported.

Manufacturer Narrative

The problem could be traced to a component failure (probably the charger).Complaint closed by the distributor without providing information to the manufacturer: impossible to determine the root cause.We are unaware about operator injury.

Event Description

The laser system had a failure that did not allow to use it properly.No adverse effects to patient were reported.

• Brand Name: OLYMPUS EMPOWER H65
• Type of Device: SURGICAL LASER
• Manufacturer (Section D): QUANTA SYSTEM S.P.A.; via acquedotto, 109; samarate, 21017 ; IT 21017
• MDR Report Key: 12009636
• MDR Text Key: 256521148
• Report Number: 3004378299-2021-00115
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 08059173390045
• UDI-Public: 08059173390045
• Combination Product (y/n): N
• PMA/PMN Number: K180423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

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
• Device Operator: No Information
• Device Model Number: EMP-H65
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/21/2021
• Initial Date FDA Received: 06/16/2021
• Supplement Dates Manufacturer Received: 05/21/2021
• Supplement Dates FDA Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1