MAUDE Adverse Event Report: UVISION360 INC. LUMINELLE DTX SYSTEM; CYSTOSCOPE

Model Number 20030

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 12/06/2021

Event Type  malfunction  

Event Description

This complaint was reported to uvision 360's distributor.According to the distributor, the customer reported scope damage; the scope stopped working while threading scissors down the sheath.There was minor damage to the blue sheath on the scope.It was also noted that there was no adverse patient event due to this malfunction.

Manufacturer Narrative

An investigation was performed and it was determined that the visual damage to the blue scope stick was likely caused by using excess force when introducing an instrument through the operative channel of the sheath.Although the scope is intended to be flexible, excessive bending can damage the fiberoptics bundles and the internal components.There were no reports of patient harm.

• Brand Name: LUMINELLE DTX SYSTEM
• Type of Device: CYSTOSCOPE
• Manufacturer (Section D): UVISION360 INC.; 158 wind chime ct,; ste. 201; raleigh NC 27615
• Manufacturer (Section G): ROBLING MEDICAL INC.; 90 weathers street; youngsville NC 27596
• Manufacturer Contact: evangelia evdaimon ; 158 wind chime ct.; ste. 201; raleigh, NC 27615 ; 8888559360
• MDR Report Key: 17552740
• MDR Text Key: 321806370
• Report Number: 3014834623-2023-00009
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Public: (01)0085327700804611)190328
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/06/2021

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: 20030
• Device Catalogue Number: LUMDTX-A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 68 KG