MAUDE Adverse Event Report: LEONI FIBER OPTICS, INC. FIBERTECH®; POWERED LASER SURGICAL INSTRUMENT

Model Number	LFS-200-SB
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The fiber broke while the physician was pushing the fiber through the scope.The broken end of the fiber touched his glove, burned through the glove and the surface of his hand.The spot was very pinpoint, and depth of penetration was limited due to distance from tissue and length of time fiber activated.There was no harm to the patient.

• Brand Name: FIBERTECH®
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LEONI FIBER OPTICS, INC.; 209 bulifants blvd; williamsburg VA 23188
• MDR Report Key: 9116174
• Report Number: 9116174
• Device Sequence Number: 2591970
• Product Code: GEX
• UDI-Device Identifier: 00816901020531
• UDI-Public: (01)00816901020531
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/10/2019
• Report Date (Section F): 09/10/2019

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: Health Professional
• Device Model Number: LFS-200-SB
• Device Catalogue Number: 095193
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 09/10/2019