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

Model Number	EMP-FBX200BHS-C
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The problem could be traced to optical fiber failure.Limited/trivial damages that would heal within short timing (mild burn) to operator were reported.No patient injury.
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.

• 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: 11611800
• Report Number: 3004378299-2021-00047
• Device Sequence Number: 4009447
• Product Code: GEX
• UDI-Device Identifier: 08033945938543
• UDI-Public: 08033945938543
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 04/03/2021

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-C
• Device Lot Number: H202601
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 04/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1