MAUDE Adverse Event Report: WEINERT FIBER OPTICS,INC. NEULIGHT; RE USABLE FIBER ASSEMBLY

Model Number	NV0635
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As the laser was being pulled back the fiber broke out side the patient 1/3 of length.

• Brand Name: NEULIGHT
• Common Device Name: RE USABLE FIBER ASSEMBLY
• Manufacturer (Section D): WEINERT FIBER OPTICS,INC.; 209 bulifants blvd; williamsburg VA 23188
• Manufacturer Contact: phillip lacroix ; 209 bulifants blvd; williamsburg, VA 23188
• MDR Report Key: 18251031
• Report Number: 3007336385-2023-00004
• Device Sequence Number: 6644575
• Product Code: GEX
• UDI-Device Identifier: 00816901023709
• UDI-Public: 00816901023709
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/01/2023

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: NV0635
• Device Lot Number: J65456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown