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

Model Number 20040 REV02

Device Problem Use of Device Problem (1670)

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

Event Date 04/19/2023

Event Type  malfunction  

Event Description

Customer complained that while using the luminelle system with a patient, the image displayed on the monitor was experiencing intermittent imaging issues.These issues were limited during scope manipulation.There was no harm to patient.

Manufacturer Narrative

Uvision 360, inc.(hereafter, uvision) performed a visual and functional testing at the uvision office.The scope presented minor kinks to the scope component that was concluded as the cause of the malfunction.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.

• 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: 16998988
• MDR Text Key: 315927262
• Report Number: 3014834623-2023-00007
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 10853277008012
• UDI-Public: (01)10853277008012(11)201001
• 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: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20040 REV02
• Device Catalogue Number: LUMDTX-A1
• Device Lot Number: 22498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2023
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2020
• 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: 40 YR
• Patient Sex: Female
• Patient Weight: 73 KG