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

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/11/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived on site to inspect the unit.During the inspection of the unit, the technician found that the hose connecting into the pressure port had split, allowing water to leak through and the reported event to occur.To resolve the issue, the technician replaced the hose connecting into the pressure port, tested the unit and found it to be operational.The unit was returned to service.A 3 year complaint review reveals this to be an isolated occurrence.No additional issues have been reported.

Event Description

The user facility reported water leaking from their innowave pro sonic irrigator.No report of injury.

• Brand Name: INNOWAVE PRO SONIC IRRIGATOR
• Type of Device: DISINFECTOR
• Manufacturer (Section D): MEDISAFE UK LTD.; unit 7 & 8, dunmow road; bishop stortford; hertforshire, CM23 5GZ; UK CM23 5GZ
• Manufacturer (Section G): MEDISAFE UK LTD.; unit 7 & 8, dunmow road; bishop stortford; hertforshire, CM23 5GZ; UK CM23 5GZ
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, oh ; 3927453
• MDR Report Key: 9948318
• MDR Text Key: 199693390
• Report Number: 9617134-2020-00001
• Device Sequence Number: 1
• Product Code: MEC
• 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: 04/10/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 04/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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