MAUDE Adverse Event Report: MEDISAFE UK LIMITED INNOWAVE; INNOWAVE ECO ULTRASONIC CLEANER

Model Number	ECO
Medical Device Problem Codes	Smoking (1585); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
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 their innowave eco ultrasonic cleaner was smoking.No report of injury.
Additional Manufacturer Narrative
A steris service technician was immediately dispatched to the user facility to inspect the ultrasonic cleaner.The technician found that one of the ultrasonic transducers had separated into two pieces and the bolt that holds the transducer together had broken off.The transducers are electromechanical components that generate ultrasonic vibrations during wash cycles.The separation of the transducer is likely to have disrupted the electrical connection, which could have resulted in overheating of the transducer's wiring and likely caused the reported smoke.The innowave eco ultrasonic cleaner is designed with heat-resistant materials and certified to iec 61010-1:2010+amd1:2016 ul 61010-1, ul 61010-1, 3rd edition 2015, can/csa-c22.2 no.61010-1-12, 3rd edition 2015 safety requirements for electrical equipment for measurement, control, and laboratory use part 1: general requirements and iec 61010-2-040:2015 safety requirements for electrical equipment for measurement, control, and laboratory use part 2-040: particular requirements for sterilizers and washer-disinfectors used to treat medical materials.In the case of damage to the transducers, the ultrasonic cleaner is designed to abort the wash cycle, emit an audible alarm, and display error code "error 39 sonic generator over current".The innowave eco ultrasonic cleaner operator manual provides users with the necessary instructions to address the alarm.It should be noted that an operator manual is shipped with every ultrasonic cleaner.The operator manual states the following to address this alarm, "switch the equipment off, then on again.If problem persists, contact supplier to arrange a qualified technician inspection." due to the damage to the ultrasonic cleaner, steris was unable to obtain the cycle logs to determine the alarm state at the time of the event.Therefore, it could not be confirmed whether the ultrasonic cleaner alarmed prior to the reported event.Additionally, the operator manual states, "caution - equipment damage do not drop items into the wash tank as this could damage the ultrasonic transducers." the ultrasonic cleaner was manufactured in 2019 making it approximately six years old at the time of the event and is under steris service agreement for maintenance activities.The last maintenance visit prior to the reported event was completed on may 30, 2025; no issues with the transducer wiring were identified at that time.The ultrasonic cleaner subject of this event was removed from service and the user facility was provided with a replacement unit.A two-year complaint review confirmed this to be an isolated event.No additional issues have been reported.

• Brand Name: INNOWAVE
• Common Device Name: INNOWAVE ECO ULTRASONIC CLEANER
• 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: 23728321
• Report Number: 9617134-2025-00015
• Device Sequence Number: 18690238
• Product Code: FLG
• UDI-Device Identifier: 00724995152765
• UDI-Public: (01)00724995152765(11)190716
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 12/05/2025

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: ECO
• Device Catalogue Number: IWECO5
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2019
• 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