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

Model Number	20030
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem 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.

• Brand Name: LUMINELLE DTX SYSTEM
• Common Device Name: 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
• Report Number: 3014834623-2023-00013
• Device Sequence Number: 15124333
• Product Code: FAJ
• UDI-Device Identifier: 00853277008046
• UDI-Public: (01)00853277008046(11)211118
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K181909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 20030
• Device Catalogue Number: LUMDTX-A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 68 KG