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

Model Number	EMP-FBX272HS
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The problem cannot be investigated since the device was not returned to the manufacturer: the device was discarded at the user facility we are unaware about operator 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: 9564197
• Report Number: 3004378299-2019-00221
• Device Sequence Number: 2824463
• Product Code: GEX
• UDI-Device Identifier: 08033945938420
• UDI-Public: 08033945938420
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K180158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2020

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 Expiration Date: 06/08/2024
• Device Model Number: EMP-FBX272HS
• Device Lot Number: H192429
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1