MAUDE Adverse Event Report: WELLSPECT HEALTHCARE NAVINA SMART SYSTEM; NAVINA SMART SYSTEM REGULAR

Model Number	69010
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	12/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The used device will not be returned to the manufacturer for investigation.Wellspect healthcare has made several attempts to collect more data about the adverse event, but this has not been possible since the device was supplied by a third-party medical supplier and not directly by the manufacturer.Furthermore, due to gdpr regulations, the manufacturer cannot request direct data from the responsible healthcare provider (surgeon).The lot number of the used device cannot be tracked, and the manufacturer has no direct contact with the patient.It is also not possible to identify which hospital treated the patient.Information about the used device, its lot number, or the patient's condition is limited.At the time of this report, we cannot conclude the root cause of the incident.Should additional facts prompt us to alter or supplement any information or conclusions contained in this report, a follow-up report will be submitted.
Event or Problem Description
A foreign incident occurred outside united states.A 65-year-old male patient, who underwent an intestinal anastomosis operation more than ten years ago, was prescribed a navina smart transanal irrigation (tai) system with a rectal balloon catheter in 2022.According to the complaint, the patient had been using transanal irrigation since his intestinal anastomosis operation ten years ago, but it is unknown which system (brand) was used before he was prescribed the navina smart tai system.According to the information communicated to the manufacturer, the patient received at-home training from the third-party medical supply representative and became familiar with the device instructions for use.The patient used the device without any problem, but on (b)(6), he was admitted to the hospital due to a bowel perforation.The perforation resulted in an emergency operation with fecal peritonitis, necessitating resection and ostomy formation, followed by the daily use of ostomy aids after the operation.At the time of the incident, the rectal balloon catheter was set to setting 5, which is the maximum balloon size (volume), with a water flow of 500 ml.

• Brand Name: NAVINA SMART SYSTEM
• Common Device Name: NAVINA SMART SYSTEM REGULAR
• 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-43121
• Manufacturer Contact: emad ramzi ; aminogatan 1; p.o. box 14; mölndal, sweden SE-43-121 ; SW SE-43121
• MDR Report Key: 20910758
• Report Number: 3009632672-2024-00022
• Device Sequence Number: 7825464
• Product Code: KNT
• UDI-Device Identifier: 07333387027364
• UDI-Public: 07333387027364
• 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: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 69010
• Device Catalogue Number: 6901065
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 12/12/2024
• 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: Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female