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

Model Number	PCF
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the lid of their innowave pcf sonic irrigator closed on an employee's hand resulting in an injury.It is unknown if medical treatment was sought or administered.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the unit and found that no loctite was observed on the lid cylinders.As there was no loctite on the lid cylinders, the lid did not operate properly resulting in the reported event.The technician applied loctite to the lid cylinders, tested the unit, confirmed it to be operating.According to specification and returned it to service.On august 2, 2024, a different steris service technician performed preventive maintenance activities on the innowave pcf sonic irrigator.During the preventive maintenance activities, the technician failed to apply loctite to the lid cylinders as required when replacing the cylinder struts.The technician was re-trained on the proper maintenance activities for the innowave pcf sonic irrigator, specifically applying loctite to the lid cylinders.No additional issues have been reported.

• Brand Name: INNOWAVE
• Common Device Name: 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; 4403927453
• MDR Report Key: 20321334
• Report Number: 9617134-2024-00004
• Device Sequence Number: 18108488
• Product Code: MEC
• UDI-Device Identifier: 00724995152710
• UDI-Public: (01)00724995152710(11)20190814
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 09/27/2024

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: 08/29/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2019
• 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