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

Model Number PVMS00052

Device Problems Failure to Deliver Energy (1211); No Device Output (1435)

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

Event Date 02/25/2022

Event Type  malfunction  

Manufacturer Narrative

No laser output probably due to a component failure.We are unaware about operator/patient injury.

Event Description

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

• Brand Name: EMPOWER H35
• Type of Device: SURGICAL LASER
• Manufacturer (Section D): QUANTA SYSTEM S.P.A.; via acquedotto, 109; samarate, 21017 ; IT 21017
• Manufacturer (Section G): QUANTA SYSTEM S.P.A.; via acquedotto, 109; samarate, 21017 ; IT 21017
• Manufacturer Contact: dario bandiera ; via acquedotto, 109; samarate, varese 21017 ; IT 21017
• MDR Report Key: 14039689
• MDR Text Key: 288908778
• Report Number: 3004378299-2022-00056
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 08033945938185
• UDI-Public: 08033945938185
• Combination Product (y/n): N
• PMA/PMN Number: K180426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 04/07/2022

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 Model Number: PVMS00052
• Device Catalogue Number: PVMS00052
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/09/2022
• Initial Date FDA Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1