MAUDE Adverse Event Report: MEDISAFE UK LIMITED INNOWAVE; ULTRASONIC IRRIGATOR

Model Number	UNITY
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee obtained a cut on their hand from a "sharp edge" of the doorstop while changing chemicals in an innowave unity 20 ultrasonic irrigator.The employee received a bandage.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the unit and confirmed damage to the doorstop which resulted in the sharp edge.To resolve the issue, the technician repaired the doorstop.The unit was tested, confirmed to be operating according to specification, and returned to service.The innowave unity 20 ultrasonic irrigator is not under a steris service contract; it is unknown who is responsible for maintenance activities.The device history record (dhr) was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.A 3-year complaint review was conducted and confirmed this to be an isolated event.No additional issues have been reported.

• Brand Name: INNOWAVE
• Common Device Name: ULTRASONIC IRRIGATOR
• Manufacturer (Section D): MEDISAFE UK LIMITED; unit 7 & 8, dunmow road; bishops stortford; hertfordshire, CM23 5GZ; UK CM23 5GZ
• Manufacturer (Section G): MEDISAFE UK LIMITED; 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: 21724191
• Report Number: 9617134-2025-00004
• Device Sequence Number: 9419100
• Product Code: MEC
• UDI-Device Identifier: 00724995193737
• UDI-Public: (01)00724995193737(11)230526
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2025

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: Health Professional
• Device Model Number: UNITY
• Device Catalogue Number: IW523546NPR
• 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: 02/28/2025
• Initial Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2023
• 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