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

Model Number 20030 REV 08

Device Problems Connection Problem (2900); Premature Separation (4045)

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

Event Date 12/08/2021

Event Type  malfunction  

Event Description

Scope and sheath(s) do not consistently attach to the device.While conducting procedures, the scope and sheath(s) become dislodged.

Manufacturer Narrative

Uvision 360 completed the technical inspection of the luminelle® dtx system received.After reviewing the received system and performing functional checks, it was determined that the received scope was functioning as intended and no physical damage was shown.When attaching various sheaths to the scope it was found that minimal lateral force could dislodge the connecting fingers, causing the malfunction the user was experiencing.Uvision did not consider this a medical device reportable event and therefore did not report this complaint when initially received due to the following: no patient harm was observed as a result of the malfunction.The malfunction could result in a fluid leak, but this would not result in any patient harm.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 (b)(6) 2023, the inspector issued an fda 483 identifying this complaint as a reportable malfunction.

• 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: 16587901
• MDR Text Key: 312286135
• Report Number: 3014834623-2023-00005
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 00853277008046
• UDI-Public: (01)00853277008046(11)230915
• 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: 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 08
• Device Catalogue Number: LUMDTX-A
• Device Lot Number: 32366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2021
• 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: 45 YR
• Patient Sex: Female
• Patient Weight: 77 KG