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

Model Number 097512

Device Problem Loss of or Failure to Bond (1068)

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

Event Date 07/20/2023

Event Type  malfunction  

Manufacturer Narrative

Unit 4 years old.No reusable tag attached.No information if used morethan required 5 times.

Event Description

Connector disengaged from fiber before use.

• Brand Name: NEULIGHT
• Type of Device: 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
• MDR Text Key: 328547175
• Report Number: 3007336385-2023-00002
• 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: Physician
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 097512
• Device Catalogue Number: NV0635
• Device Lot Number: J53638
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1