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

Model Number 20030 REV 02

Device Problems Erratic or Intermittent Display (1182); Image Display Error/Artifact (1304); Improper or Incorrect Procedure or Method (2017)

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

Event Date 06/26/2019

Event Type  malfunction  

Event 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.

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
• 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: 17552729
• MDR Text Key: 321637960
• Report Number: 3014834623-2023-00008
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 00853277008046
• UDI-Public: (01)00853277008046(11)190225
• 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: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 07/09/2019
• Initial Date FDA Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2019
• 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