MAUDE Adverse Event Report: UVISION 360, INC. LUMINELLE DTX SYSTEM; CYSTOSCOPE

Model Number 20030

Device Problems Image Display Error/Artifact (1304); Poor Quality Image (1408)

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

Event Date 06/28/2022

Event Type  malfunction  

Manufacturer Narrative

A functional test was performed on the device to determine the cause of lack of image.It was determined that the scope emits light and is functional, but no image was showing on the monitor.This indicates that the cmos connection at the distal tip was insecure.Uvision had previously implemented an improvement to the scope to resolve this issue, but this device was purchased before the improvement.When this complaint was reported, uvision 360 did not consider this a medical device reportable event and therefore based on the risk of this complaint at the time of occurrence, did not report this complaint.Upon further evaluation, it was identified that this event potentially occurred during patient use and therefore it is now considered reportable.

Event Description

The customer reported that there was no image present during a procedure, even though there was an image present prior to starting the procedure during the functionality testing.The user tried to set the device up again after the procedure and got no picture.The user did not specify if the procedure was diagnostic or operative, so a conservative approach was taken in assuming that there was a patient involved during the midst of an operative procedure.There were no reports of patient harm.

• Brand Name: LUMINELLE DTX SYSTEM
• Type of Device: CYSTOSCOPE
• Manufacturer (Section D): UVISION 360, 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: 17552745
• MDR Text Key: 321716630
• Report Number: 3014834623-2023-00014
• Device Sequence Number: 1
• Product Code: FAJ
• 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
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• 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: 07/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2022
• 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