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

Model Number 097510

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 333474234
• Report Number: 3007336385-2024-00001
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00816901023471
• UDI-Public: 00816901023471
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• 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
• Device Operator: Health Professional
• Device Model Number: 097510
• Device Catalogue Number: NV0633
• Device Lot Number: J65178
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1