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

Model Number 097512

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/19/2023

Event Type  malfunction  

Manufacturer Narrative

Unit clean break with torn jacketing.

Event Description

Fiber dislodged in patient.Doctor removed fiber.Patient confirmed unharmed.

• Brand Name: NEULIGHT
• Type of Device: 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
• MDR Text Key: 328547179
• Report Number: 3007336385-2023-00003
• 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
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 097512
• Device Catalogue Number: NV0635
• Date Manufacturer Received: 10/13/2023
• Date Device Manufactured: 03/15/2023
• 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
• Patient Outcome(s): Required Intervention