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

Model Number	EMP-H35
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The problem is due to a use error: the doctor pressed the pedal in standby mode.Obviously no laser emission is possible until switching from standby to ready mode.No adverse effects to patient were reported.
Additional Manufacturer Narrative
The problem is traced to a use error.We are unaware about operator/patient injury.

• Brand Name: OLYMPUS EMPOWER H35
• Common Device Name: 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: 14110405
• Report Number: 3004378299-2022-00067
• Device Sequence Number: 14771345
• Product Code: GEX
• UDI-Device Identifier: 08059173390038
• UDI-Public: 08059173390038
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K180426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/14/2022

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: EMP-H35
• Device Catalogue Number: PVMS00052
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown