MAUDE Adverse Event Report: UVISION 360, INC. LUMINELLE DTX SYSTEM; HYSTEROSCOPE WITH SHEATH

Model Number 20030 REV02

Device Problem Use of Device Problem (1670)

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

Event Date 07/24/2020

Event Type  malfunction  

Event Description

The image from the luminelle system scope's camera, displayed on the monitor, was experiencing intermittent freezing when the scope was being manipulated.This device problem was noticed during patient use and by informal testing by the distributor.

Manufacturer Narrative

Uvision 360, inc.(hereafter uvision) performed functional testing at the uvision office.A visual inspection of the returned product as well as product in stock was performed.A testing of the returned product per ifu instructions, testing of the mechanical components, and testing of the electrical components of the returned product were also performed.The device performed as intended, and no errors were found.The malfunction reported by the user was not able to be replicated by the uvision team.Uvision developed an action plan in the case the problem recurs.Uvision did not consider this a medical device reportable event and therefore did not report this complaint when initially received due to the following: after investigation and inspections of the returned product, there was no evidence the device was defective.No patient harm was observed as a result of the malfunction.Based on the medical advisor's qualified opinion, this malfunction was unlikely to cause serious harm or death to a patient if this malfunction were to recur.The malfunction was evaluated as a possible hazardous situation and failure mode of the device through the product hazard analysis and dfmea.All risks associated with this malfunction were deemed acceptable.The maude database was reviewed for the product code hih and it was found that no events were reported for similar devices, as defined by fda guidance "medical device reporting for manufacturers guidance for industry and food and drug administration staff 2016." following an fda routine inspection performed in february 2023, the inspector issued an fda 483 identifying this complaint as a reportable malfunction.

• Brand Name: LUMINELLE DTX SYSTEM
• Type of Device: HYSTEROSCOPE WITH SHEATH
• 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: 16587898
• MDR Text Key: 311831388
• Report Number: 3014834623-2023-00002
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 00853227708019
• UDI-Public: (01)00853227708019(11)180928
• 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: Other
• Type of Report: Initial
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20030 REV02
• Device Catalogue Number: LUMDTX-A
• Device Lot Number: 21199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2018
• 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: 45 YR
• Patient Sex: Female
• Patient Weight: 77 KG