MAUDE Adverse Event Report: QUANTA SYSTEM S.P.A. OAF FIBER; SURGICAL OPTICAL FIBER

Model Number	OAF002011
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was impossible to determine the problem root cause since the product was received not sterile and as a consequence it could not be handled by our operators.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: OAF 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: 8767123
• Report Number: 3004378299-2019-00096
• Device Sequence Number: 1707969
• Product Code: GEX
• UDI-Device Identifier: 08033945933487
• UDI-Public: 08033945933487
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K131473
• 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): 07/08/2019

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: 03/04/2023
• Device Model Number: OAF002011
• Device Lot Number: A181000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1