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

Model Number 20030 REV 09, 20040 REV 08

Device Problem Device Handling Problem (3265)

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

Event Date 02/08/2022

Event Type  malfunction  

Manufacturer Narrative

Uvision360 (hereafter uvision) received the returned product and found that the customer sent back a non-luminelle power cable and hdmi cable.Uvision performed a functional investigation and determined that when utilizing the luminelle power cable and hdmi cable, the device functioned as intended.When functional testing was performed on the power cable and hdmi cable the customer sent back, the device did not function as intended.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, it was found that the non-luminelle power cable being used with the device did not provide sufficient power to the device.- 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

The customer reported during a phone call that they were unable to produce an image in their monitor after assembling the system.The customer indicated that the system failure was caught prior to be being used with 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 NC 27596
• Manufacturer Contact: evangelia evdaimon ; 158 wind chime ct, ste. 201; raleigh, NC 27615 ; 8888559360
• MDR Report Key: 16587911
• MDR Text Key: 312233397
• Report Number: 3014834623-2023-00006
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 00853277008046
• UDI-Public: (01)00853277008046(11)211020
• 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 REV 09, 20040 REV 08
• Device Catalogue Number: LUMDTX-A & LUMDTX-A1
• Device Lot Number: 33987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2021
• 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: 47 YR
• Patient Sex: Female
• Patient Weight: 77 KG