MAUDE Adverse Event Report: WELLSPECT HEALTHCARE NAVINA SMART SYSTEM; NAVINA SMART CONTROL UNIT

Model Number	69014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A replacement navina smart unit was shipped to the user and confirmed delivered on august 12.No injuries or medical interventions were reported.The affected device was not returned, and the lot number could not be obtained despite four follow-up attempts to contact the user.Consequently, product evaluation and batch record review could not be performed.
Event or Problem Description
A user of the navina smart electronic control unit, used in conjunction with the navina smart transanal irrigation system and rectal balloon catheter, reported recurring functional issues during use.Specifically, the user experienced repeated occurrences of error codes 501 and 502 at various times during irrigation sessions.According to the user, the device becomes unresponsive during these episodes and cannot be powered off manually.The system must be left to fully discharge before it can be restarted.These malfunctions occur while the rectal balloon is inflated, preventing normal deflation via the system.As a result, the user must manually disconnect all tubing in order to remove the catheter from the rectum.A replacement navina smart unit was shipped to the user and confirmed delivered on august 12.No injuries or medical interventions were reported.The affected device was not returned, and the lot number could not be obtained.

• Brand Name: NAVINA SMART SYSTEM
• Common Device Name: NAVINA SMART CONTROL UNIT
• Manufacturer (Section D): WELLSPECT HEALTHCARE; aminogatan 1; p.o.box 14; molndal, SE-43 121; SW SE-43121
• Manufacturer (Section G): WELLSPECT HEALTHCARE; aminogatan 1; p.o. box 14; molndal, SE-43 121; SW SE-43 121
• Manufacturer Contact: emad ramzi ; aminogatan 1; p.o.box 14; molndal, SE-43-121 ; SW SE-43121
• MDR Report Key: 22870599
• Report Number: 3009632672-2025-00026
• Device Sequence Number: 8894544
• Product Code: KNT
• UDI-Device Identifier: 07333387028729
• UDI-Public: 07333387028729
• Combination Product (Y/N): N
• PMA/510(K) Number: K190977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/22/2025

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: Lay User/Patient
• Device Model Number: 69014
• Device Catalogue Number: 6901440
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Race: White