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

Model Number	EMP-H35
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer stated that the laser doesn't recognize optical fibers but, after device testing, the complaint was not confirmed and the laser worked properly.As the lithotripsy procedure lasted about three hours, it is possible that two fibers expired maximum deliverable energy has been reached.No adverse effects to patient/operator were reported.

• 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: 14166133
• Report Number: 3004378299-2022-00078
• Device Sequence Number: 5812801
• Product Code: GEX
• UDI-Device Identifier: 08059173390038
• UDI-Public: 08059173390038
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 04/21/2022

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: 03/25/2022
• Initial Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2019
• 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