MAUDE Adverse Event Report: QUANTA SYSTEM S.P.A. SINGLE USE SURGICAL OPTICAL FIBER

Model Number	EMP-FBX200BHS
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The problem may could be traced to optical fiber failure.We are unaware about operator injury.We are waiting for more information from the distributors.
Event or Problem Description
The optical fiber had a failure that did not allow to use it properly.No adverse effects to patient were reported.
Event or Problem Description
The optical fiber had a failure that did not allow to use it properly.No adverse effects to patient were reported.
Additional Manufacturer Narrative
After visual inspection fiberl looks fine without any sign of being broken.We are unware of patient involvment.We are unware of operator injury.

• Brand Name: SINGLE USE SURGICAL OPTICAL FIBER
• Common Device Name: SURGICAL OPTICAL FIBER
• Manufacturer (Section D): QUANTA SYSTEM S.P.A.; via acquedotto, 109; samarate, 21017 ; IT 21017
• MDR Report Key: 10211357
• Report Number: 3004378299-2020-00090
• Device Sequence Number: 11536572
• Product Code: GEX
• UDI-Device Identifier: 08033945938468
• UDI-Public: 08033945938468
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K180158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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-FBX200BHS
• Device Lot Number: H194034
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1