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

Model Number	20030 REV 02
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Image Display Error/Artifact (1304); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they were experiencing intermittent images from the scope on the monitor.The customer sent images of a physical damage they notice as well.Clear damage to the fiber optic stick was visible in the images.The fiber optic cable was visually and functionally tested to confirm the physical and functional damage seen by the customer.The usage communicated by the customer was recreated in an attempt to recreate the damage.The damage could not be recreated using the same instrumentation used with the device.There was no report of patient harm.
Additional Manufacturer Narrative
An investigation was performed which determined that the root cause of the malfunction was due to damage to the fiber optic stick.The cause of damage to the fiber optic stick was due to apparent misuse by the customer.No patient harm was reported due to this malfunction.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 occurred during patient use and therefore it is now considered reportable.

• 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: 17552729
• Report Number: 3014834623-2023-00008
• Device Sequence Number: 20553082
• Product Code: FAJ
• UDI-Device Identifier: 00853277008046
• UDI-Public: (01)00853277008046(11)190225
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/26/2019

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 REV 02
• Device Catalogue Number: LUMDTX-A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2019
• 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