MAUDE Adverse Event Report: MEDISAFE UK LTD. INNOWAVE ULTRA PCF SONIC IRRIGATOR

Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that an employee experienced an "electrical shocking sensation" after she touched the innowave ultra pcf sonic irrigator.No report of injury.
Additional Manufacturer Narrative
A steris service technician inspected the innowave ultra pcf sonic irrigator and found the unit to be operating to specifications.No issues were noted with wiring, ground connections and no visible electrical shorts were identified.Unrelated to the reported event and during the technician's test cycles, it was observed that a loud noise was coming from the circulation pump.The technician found an obstruction in the pump tubing.The obstruction was removed, and the noise was resolved.As a proactive repair, the steris technician replaced the circulation pump, ran a test cycle and confirmed the unit to be operating properly.The steris service technician returned the innowave ultra pcf sonic irrigator to service.Following the reported event, the steris service technician learned from user facility personnel that the facility's gfci (ground-fault circuit interrupter) had tripped.User facility personnel had their gfci inspected by a third-party electrician.No issues were noted with the function or operation.Out of an abundance of caution, the user facility elected to have their gfci facility outlet replaced.No additional issues have been reported.

• Brand Name: INNOWAVE ULTRA PCF SONIC IRRIGATOR
• Common Device Name: SONIC IRRIGATOR
• 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; 4403927453
• MDR Report Key: 18161862
• Report Number: 9617134-2023-00005
• Device Sequence Number: 12397436
• Product Code: FLG
• UDI-Device Identifier: 00724995152734
• UDI-Public: 00724995152734
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Date (Section B): 11/17/2023

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
• 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: 10/19/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2022
• 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