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

Model Number	20020 REV03
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Uvision 360, inc.(hereafter, uvision) performed functional testing at the uvision office.Visual inspection was performed on the returned product as well as product in stock.Testing of the product per ifu instructions and testing of mechanical components were completed on the returned product.The sheath performed as intended, and the malfunction experienced by the user could not be replicated.Uvision additionally reviewed the manufacturing and inspection records for the associated device lot to ensure that the entire device lot met all acceptance criteria prior to release for distribution.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.Following an fda routine inspection performed in (b)(6) 2023, the inspector issued an fda 483 identifying this complaint as a reportable malfunction.
Event or Problem Description
Fluid was visibly not flowing through the scope's outflow fluid tube.

• 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: 16587896
• Report Number: 3014834623-2023-00001
• Device Sequence Number: 5729192
• Product Code: HIH
• UDI-Device Identifier: 00853277008008
• UDI-Public: (01)00853277008008(17)201001(10)9080
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Inspection,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 Expiration Date: 10/01/2020
• Device Model Number: 20020 REV03
• Device Catalogue Number: LUMDTX-360
• Device Lot Number: 9080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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