MAUDE Adverse Event Report: MEDISAFE UK LTD. INNOWAVE PCF SONIC IRRIGATOR; WASHER/DISINFECTOR

Model Number	PCF
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived on site to inspect the innowave pcf sonic irrigator and found that the gas spring did not extend all the way causing the lid to not fully open.As a result, the lid could not stay open and closed on the employee's hand resulting in the reported event.The technician replaced the gas spring, tested the unit, confirmed it to be operating according to specification, and returned it to service.The innowave pcf sonic irrigator is not under steris service agreement for maintenance activities.The user facility is responsible for all maintenance activities.No additional issues have been reported.
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 to their finger; the employee returned to work.No report of medical treatment sought or administered.

• Brand Name: INNOWAVE PCF SONIC IRRIGATOR
• Common Device Name: WASHER/DISINFECTOR
• Manufacturer (Section D): MEDISAFE UK LTD.; unit 7 & 8, dunmow road; bishops stortford; hertfordshire, CM23 5GZ; UK CM23 5GZ
• Manufacturer (Section G): MEDISAFE UK LTD.; unit 7 & 8, dunmow road; bishops stortford; hertfordshire, CM23 5GZ; UK CM23 5GZ
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 15775188
• Report Number: 9617134-2022-00008
• Device Sequence Number: 15117642
• Product Code: MEC
• UDI-Device Identifier: 00724995152710
• UDI-Public: 00724995152710
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 11/10/2022

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: 10/12/2022
• Initial Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2018
• 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