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

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2021

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the innowave pro sonic irrigator and found that the hose connecting into the pressure port had split allowing water to leak from the unit.The technician replaced the hose, tested the unit, confirmed it to be operating according to specification, and returned it to service.No additional issues have been reported.

Event Description

The user facility reported that water was leaking from their innowave pro sonic irrigator onto the floor.No report of injury.

• Brand Name: INNOWAVE PRO SONIC IRRIGATOR
• Type of Device: WASHER/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 44060 ; 4403927453
• MDR Report Key: 11701375
• MDR Text Key: 260250630
• Report Number: 9617134-2021-00005
• 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: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• 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
• Date Manufacturer Received: 03/24/2021
• 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