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

Model Number 20030

Device Problem Material Twisted/Bent (2981)

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

Event Date 08/01/2023

Event Type  malfunction  

Event Description

The customer reported that they noticed the blue casing of the scope is starting to tear.They reported the scope had only been used in two cases.The customer provided photos of the physical damage to the scope stick.There were no reports of patient harm.

Manufacturer Narrative

As of the time of this submission, uvision has not yet received the system for a full investigation.Since this event was reported by the same facility as previous complaint, which was attributed to the use of incompatible isntruments with teh device, based on the timing of this report, it is believed that the root cause is the same.Once the device is received, uvision will perform an investigation and if a new root cause is identified or if any additional information is provided by the user facility, then a supplemental report will be submitted.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: 17552750
• MDR Text Key: 321717203
• Report Number: 3014834623-2023-00013
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 00853277008046
• UDI-Public: (01)00853277008046(11)211118
• 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: 08/01/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• 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