MAUDE Adverse Event Report: WEINERT FIBER OPTICS, INC. NEULIGHT; FIBER OPTIC DELIVERY SYSTEM

Model Number	097510
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Event or Problem Description
Fiber broke upon firing laser.The fiber was removed in office and patient was discharged with stitches.Patient is stable.No other information was given.
Additional Manufacturer Narrative
Information given is fiber broke and was removed from patient at the time of procedure.Stitches and patient was discharged.Manufacturer has not received device for investigation.

• Brand Name: NEULIGHT
• Common Device Name: FIBER OPTIC DELIVERY SYSTEM
• Manufacturer (Section D): WEINERT FIBER OPTICS, INC.; 209 bulifants blvd.; williamsburg VA 23188
• Manufacturer (Section G): WEINERT FIBER OPTICS,INC.; 209 bulifants bkvd; williamsburg VA 23188
• Manufacturer Contact: phillip lacroix ; 209 bulifants blvd.; williamsburg, VA 23188
• MDR Report Key: 18563676
• Report Number: 3007336385-2024-00001
• Device Sequence Number: 6810765
• Product Code: GEX
• UDI-Device Identifier: 00816901023471
• UDI-Public: 00816901023471
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial

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?: No
• Operator of Device: Health Professional
• Device Model Number: 097510
• Device Catalogue Number: NV0633
• Device Lot Number: J65178
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown