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

Model Number	097512
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unit clean break with torn jacketing.
Event or Problem Description
Fiber dislodged in patient.Doctor removed fiber.Patient confirmed unharmed.

• Brand Name: NEULIGHT
• Common Device Name: FIBER OPTIC DELIVERY DEVICE
• Manufacturer (Section D): WEINERT FIBER OPTICS, INC.; williamsburg VA 23188
• Manufacturer Contact: phillip lacroix ; 209 bulifants blvd.; williamsburg, VA 23188 ; 7572584805
• MDR Report Key: 18171278
• Report Number: 3007336385-2023-00003
• Device Sequence Number: 7567901
• Product Code: GEX
• UDI-Device Identifier: 00816901023709
• UDI-Public: 00816901023709
• 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: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 097512
• Device Catalogue Number: NV0635
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 11/20/2023
• Date Device Manufactured: 03/15/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown