MAUDE Adverse Event Report: FORTEC FIBERS, INC. / LEONI FIBER OPTICS, INC. SMARTSCOPE ROUNDED TIP HOLMIUM LASER FIBERS; POWERED LASER SURGICAL INSTRUMENT

Model Number	SU-365-RT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During the use of the holmium 365um laser fiber during a urology procedure, the laser fiber broke approximately 12 inches from the tip as the fiber was being manipulated by the physician.A small flash was seen.Procedure was stopped immediately.Safety check completed.No physical injury or burns to physician or patient.New fiber was used.Single use - 365um bare holmium laser fiber.

• Brand Name: SMARTSCOPE ROUNDED TIP HOLMIUM LASER FIBERS
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): FORTEC FIBERS, INC. / LEONI FIBER OPTICS, INC. ; streetsboro OH
• MDR Report Key: 8253666
• Report Number: MW5083163
• Device Sequence Number: 1616679
• Product Code: GEX
• UDI-Device Identifier: 00816901020272
• UDI-Public: (01)00816901020272
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/21/2018

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 Expiration Date: 09/25/2022
• Device Model Number: SU-365-RT
• Device Catalogue Number: 096875
• Device Lot Number: J43297
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2019
• 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: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 94