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

Model Number	EMP-FBX272HS-C
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Optical fiber failure.We are unaware about operator/patient injury.
Event or Problem Description
Fiber boke during procedure.

• Brand Name: OLYMPUS EMPOWER SURGICAL LASER FIBER
• Common Device Name: SURGICAL LASER FIBER
• Manufacturer (Section D): QUANTA SYSTEM S.P.A.; via acquedotto, 109; samarate, 21017 ; IT 21017
• MDR Report Key: 11691800
• Report Number: 3004378299-2021-00067
• Device Sequence Number: 3511499
• Product Code: GEX
• UDI-Device Identifier: 08033945938529
• UDI-Public: 08033945938529
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180158
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/19/2021

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
• Operator of Device: No Information
• Device Model Number: EMP-FBX272HS-C
• Device Lot Number: H204328
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1