MAUDE Adverse Event Report: MEDISAFE UK LTD. INNOWAVE ULTRA + SONIC IRRIGATOR

Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician inspected the unit and found that the rubber washer in the cold waterline required replacement.The cold waterline connects from the innowave ultra + sonic irrigator to the facility's cold water outlet.The steris technician replaced the rubber washer, tested the function and operation of the unit, and confirmed it to be operating properly.The innowave ultra + sonic irrigator was returned to service and no additional issues have been reported.
Event or Problem Description
The user facility reported that water was leaking from their innowave ultra plus sonic irrigator.No report of injury.

• Brand Name: INNOWAVE ULTRA + SONIC IRRIGATOR
• Common Device Name: SONIC IRRIGATOR
• Manufacturer (Section D): MEDISAFE UK LTD.; unit 7 & 8, dunmow road; bishops stortford; hertfordshire, CM23 5GZ; UK CM23 5GZ
• Manufacturer (Section G): MEDISAFE UK LTD.; unit 7 & 8, dunmow road; bishops stortford; hertfordshire, CM23 5GZ; UK CM23 5GZ
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor; 4403927453
• MDR Report Key: 19034064
• Report Number: 9617134-2024-00001
• Device Sequence Number: 8167847
• Product Code: FLG
• UDI-Device Identifier: 00724995152727
• UDI-Public: 00724995152727
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2024

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown