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

Model Number Pro

Device Problem Device Fell (4014)

Patient Problem Laceration(s) (1946)

Event Date 09/20/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 307035989
• Report Number: 9617134-2022-00007
• Device Sequence Number: 1
• Product Code: MEC
• UDI-Device Identifier: 00724995152741
• UDI-Public: 00724995152741
• 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
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: Pro
• Device Catalogue Number: IWPRO60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2018
• 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