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

Device Problems Device Emits Odor (1425); Smoking (1585)

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

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the sonic irrigator.The technician found the unit's transducers located in the back of the electrical cabinet and wiring were damaged based on the technician's inspection, the root cause of the reported event can be attributed to a loose wire within the sonic irrigator.The loose wire created an electric arc, causing damage to the transducers and the reported event to occur.The technician made the necessary repairs, ran a test cycle, confirmed the sonic irrigator to be operating according to specification, and returned it to service.A 2-year complaint review indicates this to be an isolated event.No additional issues have been reported.

Event Description

The user facility reported a burning smell and smoke coming from their sonic irrigator.No report of injury.

• Brand Name: 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: 9432632
• MDR Text Key: 176222643
• Report Number: 9617134-2019-00002
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• 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: 11/07/2019
• 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