MAUDE Adverse Event Report: MEDISAFE UK LTD. INNOWAVE PCF SONIC IRRIGATOR

Device Problem Device Fell (4014)

Patient Problem Pain (1994)

Event Date 10/16/2023

Event Type  malfunction  

Event Description

The user facility reported that the lid of their innowave pcf sonic irrigator closed on an employee's arm resulting in an injury.Medical treatment was sought and administered.

Manufacturer Narrative

A steris service technician arrived onsite to inspect the unit and found that no loctite was present on the lid cylinders.As there was no loctite on the lid cylinders, the lid did not operate properly resulting in the reported event.The technician applied loctite to the lid cylinders, tested the unit, confirmed it to be operating according to specification, and returned it to service.On june 16, 2023, a different steris service technician performed preventive maintenance activities on the innowave pcf sonic irrigator.During the preventive maintenance activities, the technician failed to apply loctite to the lid cylinders as directed in the preventive maintenance instructions.The technician was re-trained on the proper maintenance activities for the innowave pcf sonic irrigator, specifically applying loctite to the lid cylinders.No additional issues have been reported.

• Brand Name: INNOWAVE PCF SONIC IRRIGATOR
• Type of Device: SONIC IRRIGATOR
• 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; 4403927453
• MDR Report Key: 18093149
• MDR Text Key: 328654193
• Report Number: 9617134-2023-00004
• Device Sequence Number: 1
• Product Code: MEC
• UDI-Device Identifier: 00724995152710
• UDI-Public: 00724995152710
• 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: 11/08/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2020
• 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