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

Model Number	PCF
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the event is currently in progress.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that an employee observed water to be leaking from the lid of their innowave ultrasonic pcf irrigator.The employee approached the unit, proceeded to open the lid, subsequently causing hot water to contact her.It is unknown at this time whether medical treatment was sought or administered.
Additional Manufacturer Narrative
A steris service technician arrived onsite and found the circuit board and generator board required replacement.The technician replaced the boards, tested the function and operation of the device, confirmed it to be operating to specification, and returned it to service.The circuit board and generator board were returned for evaluation.Evaluation results determined that the power supply within the boards had failed subsequently causing them to short circuit and the reported event to occur.The cause of the power supply failure could not be determined.No additional issues have been reported.

• Brand Name: INNOWAVE
• Common Device Name: INNOWAVE ULTRASONIC PCF 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: 23381389
• Report Number: 9617134-2025-00009
• Device Sequence Number: 21094063
• Product Code: MEC
• UDI-Device Identifier: 00724995152710
• UDI-Public: (01)00724995152710(11)220120
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 10/24/2025

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: Health Professional
• Device Model Number: PCF
• Device Catalogue Number: IWPCF
• 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: 09/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• 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