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

Model Number	EMP-FBX272HS
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Blister (4537)
Date of Event	01/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The problem is under investrigation and could be traced to a component failure.Limited/trivial damages that would heal within short timing (small blister) to operator were reported.We are waiting for the fiber to be returned.
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
The problem could be traced to optical fiber failure.Limited/trivial damages that would heal within short timing (small blister) to operator 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.

• 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: 9671490
• Report Number: 3004378299-2020-00004
• Device Sequence Number: 2573671
• Product Code: GEX
• UDI-Device Identifier: 08033945938420
• UDI-Public: 08033945938420
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 01/26/2021

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-FBX272HS
• Device Lot Number: H193711
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 02/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1