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

Model Number	Pro
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris technician arrived onsite to inspect the innowave pro sonic irrigator and found that the basket was bent causing it to be misaligned with the shelf.This misalignment allowed the basket to fall resulting in the reported event.The technician made adjustments to the basket to fit properly on the unit shelf rack, tested the unit, confirmed it to be operating according to specifications, and returned to service.The innowave pro sonic irrigator operator manual states (52), "baskets require considerate care and regular inspection.Baskets treated harshly are susceptible to damage.Baskets should always be inspected before any loading of instruments." the technician counseled user facility personnel on inspecting baskets for damage prior to use.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee obtained a cut on their hand when attempting to catch a falling basket as it was being removed from their innowave pro sonic irrigator.The employee received stitches due to the reported event.

• Brand Name: INNOWAVE PRO 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: 15651389
• Report Number: 9617134-2022-00007
• Device Sequence Number: 2356629
• Product Code: MEC
• UDI-Device Identifier: 00724995152741
• UDI-Public: 00724995152741
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 10/21/2022

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: Pro
• Device Catalogue Number: IWPRO60
• 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: 09/21/2022
• Initial Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2018
• 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