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

Model Number 20050 REV 01

Device Problems Erratic or Intermittent Display (1182); No Display/Image (1183)

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

Event Date 09/11/2020

Event Type  malfunction  

Manufacturer Narrative

Uvision 360, inc.(hereafter uvision) performed functional testing at the uvision 360 office.The device did not perform as intended, however, the issue had already been addressed by uvision through an update to the design.This improvement was released after the sale date of this system.Uvision did not consider this a medical device reportable event and therefore did not report this complaint when initially received due to the following: the malfunction was an isolated event as the improvement was released to address the malfunction type after the malfunction occurred.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 februrary 2023, the inspector issued an fda 483 identifying this complaint as a reportable malfunction.

Event Description

Dr.Machin was performing an iud removal and the image on the monitor went out.The staff was able to move the cord and the image re-appeared to complete the procedure.The patient has been reported as doing fine.The physician reported no injury or impact to the patient.

• 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 27596
• Manufacturer Contact: evangelia evdaimon ; 158 wind chime ct, ste. 201; raleigh, NC 27615 ; 8888559360
• MDR Report Key: 16587903
• MDR Text Key: 312201077
• Report Number: 3014834623-2023-00003
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 10853277008029
• UDI-Public: (01)10853277008029(11)190214
• 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: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/21/2023

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
• Device Operator: Health Professional
• Device Model Number: 20050 REV 01
• Device Catalogue Number: LUMDTX-A3
• Device Lot Number: 22363
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 77 KG