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

Model Number	UNITY
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the unit and found that the lid's hinge to the innowave unity broke resulting in the reported event.While onsite the technician replaced the lid hinge, tested the unit, found it to be operating according to specification, and returned the unit to service.No additional issues have been reported.
Event or Problem Description
The user facility reported that smoke was emitting from their innowave pcf sonic irrigator.No report of injury.

• Brand Name: INNOWAVE
• Common Device Name: SONIC 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; 4402597401
• MDR Report Key: 25228660
• Report Number: 9617134-2026-00002
• Device Sequence Number: 14734947
• Product Code: FLG
• UDI-Device Identifier: 00724995193737
• UDI-Public: (01)00724995193737(11)220729
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/20/2026

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: 04/20/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2022
• 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