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

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

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

Event Date 02/23/2023

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the unit subject of the reported event.During the technicians initial inspection, he found that the water level was low.The medisafe sonic irrigator pcf was removed from service.A follow-up report will be submitted upon completion of inspection and repairs to the medisafe sonic irrigator pcf unit.

Event Description

The user facility reported that smoke was emitting from their medisafe sonic irrigator pcf.No report of injury.

Manufacturer Narrative

A steris service technician inspected the medisafe sonic irrigator pcf and found that the unit's water level was low.The low water level may have contributed to the reported event however, a definite root cause could not be determined.The steris service technician reviewed previous cycle printouts and no discrepancies were noted.The steris service technician made repairs to the medisafe sonic irrigator pcf, tested the unit and returned the device to service.No additional issues have been reported.

• Brand Name: MEDISAFE SONIC IRRIGATOR PCF
• Type of Device: 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; 4403927453
• MDR Report Key: 16592844
• MDR Text Key: 312295687
• Report Number: 9617134-2023-00001
• 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,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• 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: 02/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2016
• 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