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

Model Number	097512
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unit 4 years old.No reusable tag attached.No information if used morethan required 5 times.
Event or Problem Description
Connector disengaged from fiber before use.

• Brand Name: NEULIGHT
• Common Device Name: FIBER OPTIC DELIVERY SYSTEM
• Manufacturer (Section D): WEINERT FIBER OPTICS, INC.; 209 bulifants blvd; williamsburg VA 23188
• Manufacturer Contact: phillip lacroix ; 209 bulifants blvd; williamsburg, VA 23188 ; 7572584805
• MDR Report Key: 18171277
• Report Number: 3007336385-2023-00002
• Device Sequence Number: 7567900
• Product Code: GEX
• UDI-Device Identifier: 00816901023709
• UDI-Public: 00816901023709
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 097512
• Device Catalogue Number: NV0635
• Device Lot Number: J53638
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2019
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown