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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Electric Shock (2554)

Event Date 10/19/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 328424054
• Report Number: 9617134-2023-00005
• Device Sequence Number: 1
• Product Code: FLG
• UDI-Device Identifier: 00724995152734
• UDI-Public: 00724995152734
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1