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

Model Number	20030
Medical Device Problem Codes	Erratic or Intermittent Display (1182); No Display/Image (1183); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• 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: 17552749
• Report Number: 3014834623-2023-00012
• Device Sequence Number: 6683984
• Product Code: FAJ
• UDI-Device Identifier: 00853277008046
• UDI-Public: (01)00853277008046(11)210331
• 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): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2021
• 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