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

Model Number NV0635

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/10/2023

Event Type  malfunction  

Event Description

As the laser was being pulled back the fiber broke out side the patient 1/3 of length.

• Brand Name: NEULIGHT
• Type of Device: 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
• MDR Text Key: 330571305
• Report Number: 3007336385-2023-00004
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00816901023709
• UDI-Public: 00816901023709
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1