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

Model Number	PCF
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that water was leaking from their innowave pcf sonic irrigator onto the floor.No report of injury.
Additional Manufacturer Narrative
The investigation of the subject event is in process.A follow-up mdr will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The innowave pcf sonic irrigator subject of the event was inspected; however, a specific root cause could not be determined.The reported event has not recurred since (b)(6) 2022.There is no evidence to suggest that this is a systemic issue.No additional issues have been reported.

• 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: 15212002
• Report Number: 9617134-2022-00005
• Device Sequence Number: 11289833
• Product Code: MEC
• UDI-Device Identifier: 00724995152710
• UDI-Public: 00724995152710
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 07/16/2022
• Supplement Date Received by Manufacturer: 07/16/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2021
• 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