MAUDE Adverse Event Report: QUANTA SYSTEM S.P.A. OFH FIBER; OPTICAL LASER FIBER

Catalog Number	EMP-FBX200BHS
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The problem was due to a component failure.We are unaware about operator injury.We are waiting for additional information from the distributor.
Event or Problem Description
The single use optical fiber had a failure that did not allow to use it.No adverse effects to patient were reported.
Additional Manufacturer Narrative
It was not possible to determine the root cause since the device was discarded.We are unaware about operator injury.
Event or Problem Description
The single use optical fiber had a failure that did not allow to use it.No adverse effects to patient were reported.

• Brand Name: OFH FIBER
• Common Device Name: OPTICAL LASER FIBER
• Manufacturer (Section D): QUANTA SYSTEM S.P.A.; via acquedotto, 109; samarate, 21017 ; IT 21017
• MDR Report Key: 8402789
• Report Number: 3004378299-2019-00030
• Device Sequence Number: 16651558
• Product Code: GEX
• UDI-Device Identifier: 08033945937973
• UDI-Public: 08033945937973
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2019

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: 11/04/2023
• Device Catalogue Number: EMP-FBX200BHS
• Device Lot Number: H184512
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 11/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1