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

Catalog Number	OFH702713
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The problem was due to a component failure.We are unaware about patient injury.We are waiting for additional information from the distributor.
Event or Problem Description
The optical fiber had a failure that did not allow to use it.No adverse effects to patient were reported.
Event or Problem Description
The optical 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 a communication issue.We are unaware about patient injury.

• Brand Name: OFH 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: 8343342
• Report Number: 3004378299-2019-00013
• Device Sequence Number: 11196154
• Product Code: GEX
• UDI-Device Identifier: 08033945938093
• UDI-Public: 08033945938093
• 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
• Remedial Action: Inspection,Other
• 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 Catalogue Number: OFH702713
• Device Lot Number: H182810
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 02/15/2019
• 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