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

Model Number	PCF
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported the lid to their innowave pcf sonic irrigator fell on an employee's hand while loading a tray into the unit.Medical treatment was sought, however it is unknown if any medical treatment was administered.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the innowave pcf sonic irrigator and found the gas strut was losing the pressure needed to hold the lid open and required replacement.The technician replaced the gas strut and repaired the lid assembly, tested the unit, confirmed it to be operating according to specification, and returned it to service.No additional issues have been reported.

• 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: 23617404
• Report Number: 9617134-2025-00014
• Device Sequence Number: 18653255
• Product Code: MEC
• UDI-Device Identifier: 00724995152710
• UDI-Public: (01)00724995152710(11)200415
• 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): 11/21/2025

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: 10/22/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2020
• 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