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

Model Number	EMP-FBX272HS
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The problem was due to optical fiber failure.We are unaware about operator injury.We are waiting for additional information from distributor.
Event or Problem Description
Hold gt the laser fiber had a failure that did not allow to use it.No adverse effects to patient were reported.
Additional Manufacturer Narrative
The problem was due to optical fiber failure.It was not possible to determine the root cause since the device was not returned.We are unaware about operator injury.
Event or Problem Description
The laser fiber had a failure that did not allow to use it.No adverse effects to patient were reported.

• Brand Name: SINGLE USE SURGICAL OPTICAL FIBER
• Common Device Name: SURGICAL LASER FIBER
• Manufacturer (Section D): QUANTA SYSTEM S.P.A.; via acquedotto, 109; samarate, 21017 ; IT 21017
• MDR Report Key: 8878275
• Report Number: 3004378299-2019-00126
• Device Sequence Number: 2538232
• Product Code: GEX
• UDI-Device Identifier: 08033945938420
• UDI-Public: 08033945938420
• 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
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

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: 12/10/2023
• Device Model Number: EMP-FBX272HS
• Device Catalogue Number: EMP-FBX272HS
• Device Lot Number: H185013
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1