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

Model Number	PCF
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris has requested the connector subject of the reported event to be returned for evaluation.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 a connector in their innowave pcf sonic irrigator was "partially" melted.No report of injury.
Additional Manufacturer Narrative
A steris service technician inspected the unit following the reported event and found that a circuit connector had overheated.The cause could not be determined however it is possible the components may have been exposed to liquid which could result in a short circuit resulting in the reported event.Contrary to the initial report, the circuit connector was not returned for evaluation.The technician repaired the unit, tested the function and operation and confirmed it to be operating to specifications.The innowave pcf sonic irrigator was returned to service and no additional issues have been reported.
Additional Manufacturer Narrative
A steris service technician was immediately dispatched to the user facility to inspect the sonic irrigator.The technician found damage to the electrical connector.The damage observed is indicative of the connector overheating which likely resulted in the reported smoke or fire.The cause of the damage to the connector has not been determined.The innowave pcf sonic irrigator is designed with heat-resistant materials and certified to iec 61010-1:2010+amd1:2016, ul 61010-1, 3rd edition may 1 2012, revised july 19, 2019, can/csa-c22.2 no.61010-1-12 (2012-05), 3rd edition, with revisions through 2018-11, safety requirements for electrical equipment for measurement, control, and laboratory use part 1: general requirements, en 61326-1:2020 bs en/iec 61326-1:2021, electrical equipment for measurement, control and laboratory use, emc requirements, general requirements, and iec 61010-2-040:2020, ed.3.0, 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.If the ultrasonic generator draws too much current due to the damaged connector, then the sonic irrigator is designed to abort the wash cycle, emit an audible alarm, and display error code "sonic generator over current".The operator manual states the following to address this alarm, "use the electrical disconnect switch to turn the equipment power off then back on.If the problem persists call steris." the technician made the necessary repairs to the unit, tested the unit, confirmed it to be operating according to specifications, and returned it to service.No additional issues have been reported.A follow-up mdr will be submitted should additional information become available.

• 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: 23381390
• Report Number: 9617134-2025-00010
• Device Sequence Number: 9046722
• Product Code: MEC
• UDI-Device Identifier: 00724995152710
• UDI-Public: (01)00724995152710(11)200814
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,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; Not provided
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 02/16/2026; 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2020
• 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