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

Model Number 20030

Device Problems Erratic or Intermittent Display (1182); No Display/Image (1183); Deformation Due to Compressive Stress (2889)

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

Event Date 07/10/2023

Event Type  malfunction  

Event Description

The customer reported that the loaner scope was damaged during a patient procedure.The customer explained that there was severe damage to the blue scope stick, but did not specify how the damage occurred.There were no patient adverse events due to this malfunction.

Manufacturer Narrative

Based on investigation, physician used two sets of incompatible scissors resulting to physical damage on the blue scope stick, which caused the failure of the image light.Although the scope is intended to be flexible, excessive bending can damage the fiberoptics bundles and the internal components.Such damage will compromise the light illuminating fibers at the distal end of the scope.The damage to the fiberoptics can occur when a user mishandles the product and uses incompatible instruments.There were no reports of patient harm.A notification was sent to all customers as a reminder of the possible damage that can occur when using incompatible instruments.

• 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 st; youngsville NC 27596
• Manufacturer Contact: evangelia evdaimon ; 158 wind chime ct; ste. 201; raleigh, NC 27615 ; 8888559360
• MDR Report Key: 17552749
• MDR Text Key: 321585834
• Report Number: 3014834623-2023-00012
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 00853277008046
• UDI-Public: (01)00853277008046(11)210331
• 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: Notification
• Type of Report: Initial
• Report Date: 07/27/2023

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: 07/27/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2021
• 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