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

Model Number	20030 REV 03
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
In a pre-sale demonstration, the surgeon was using the luminelle dtx system for a cystoscopy procedure and the sales representative reported that the visibility was very dark.The sales representative and surgeon said that it was difficult to view the bladder unless the scope was very close to the bladder wall.
Additional Manufacturer Narrative
After the product malfunctioned, the surgeon was able to perform 2 iud removal procecdures successfully later in the day with no errors.Uvision360, inc.(hereafter uvision) performed visual inspection on the returned product at the uvision office.The device was put together following the ifu and performed 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, 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 februrary 2023, the inspector issued an fda 483 identifying this complaint as a reportable malfunction.Additional research was performed in the maude database for product code faj and it was found that events had been reported for similar devices under this product code.

• Brand Name: LUMINELLE DTX SYSTEM
• Common Device Name: 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: 16587900
• Report Number: 3014834623-2023-00004
• Device Sequence Number: 20307202
• Product Code: FAJ
• UDI-Device Identifier: 00853277008046
• UDI-Public: (01)00853277008046(11)200716
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 20030 REV 03
• Device Catalogue Number: LUMDTX-A
• Device Lot Number: 29726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 77 KG