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

Model Number	PCF
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the innowave pcf sonic irrigator and found that one of the gas struts required repair.The technician reassembled the gas strut, tested the function and operation of the device and confirmed it to be operating to specification.The technician returned the unit to service, and no additional issues have been reported.
Event or Problem Description
The user facility reported that the gas strut supporting the lid to their innowave pcf sonic irrigator detached resulting in an arm injury to an employee.The employee sought and received medical treatment.

• Brand Name: INNOWAVE
• Common Device Name: INNOWAVE PCF 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: 23728320
• Report Number: 9617134-2025-00016
• Device Sequence Number: 9210998
• Product Code: MEC
• UDI-Device Identifier: 00724995152710
• UDI-Public: (01)00724995152710(11)210716
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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?: Yes
• Is this a Product Problem Report?: No
• 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: 11/07/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2021
• 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