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

Model Number	EMP-FBX200BHS
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2019
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 distributor.
Event or Problem Description
Two optical fibers had a failure that did not allow to use them properly.They were used with empower 35 laser (serial number: (b)(4)).No adverse effects to patient were reported.
Additional Manufacturer Narrative
It was not possible to determine the root cause since the device was discarded - no investigation performed.We are unaware about operator injury.
Event or Problem Description
Two optical fibers had a failure that did not allow to use them properly.They were used with empower 35 laser (serial number: (b)(4)).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: 8850491
• Report Number: 3004378299-2019-00122
• Device Sequence Number: 372300
• Product Code: GEX
• UDI-Device Identifier: 08033945938468
• UDI-Public: 08033945938468
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 11/19/2023
• Device Model Number: EMP-FBX200BHS
• Device Catalogue Number: EMP-FBX200BHS
• Device Lot Number: H184740
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EMPOWER H35 (B)(4); EMPOWER H35 (B)(4); EMPOWER H35 ((B)(4)); EMPOWER H35 ((B)(4))