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

Device Problems Smoking (1585); Insufficient Information (3190)

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

Event Date 11/08/2021

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the innowave pcf sonic irrigator and found it to not be operational.The unit was removed from service.Steris has requested that the unit of the event be returned to steris for evaluation.A follow-up mdr will be submitted when additional information becomes available.

Event Description

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

Manufacturer Narrative

The unit was able to be evaluated at the user facility, therefore, it was not returned to steris.A steris service technician inspected the unit and found that a transducer had detached.The detached transducer caused the unit to overheat subsequently resulting in the reported smoke.Prior to the reported event the unit had alarmed error code 50 internal ambient temperature too high.The operator manual states the following in response to error code 50 (page 118), "turn equipment off and leave for 1 hour to cool down.If problem persists, contact supplier to arrange a qualified technician inspection." the user facility was provided with a replacement unit.No additional issues have been reported.

• Brand Name: INNOWAVE PCF SONIC IRRIGATOR
• Type of Device: WASHER/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, OH 44060 ; 4403927453
• MDR Report Key: 12962528
• MDR Text Key: 287286337
• Report Number: 9617134-2021-00009
• 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: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• 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: 11/08/2021
• 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