MAUDE Adverse Event Report: MEDIVATORS, INC. DSD EDGE AUTOMATED ENDOSCOPE REPROCESSOR; ENDOSCOPE REPROCESSING SYSTEM

Device Problem Smoking (1585)

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

Event Date 03/16/2022

Event Type  malfunction  

Event Description

The user facility reported that smoke was emitting from inside their dsd edge aer.No report of injury.

Manufacturer Narrative

A medivators service technician arrived onsite to inspect the unit and found the ground fault interrupter (gfi) was charred.Through further inspection, the technician found that the unit was leaking from a cracked overflow coupling.The gfi became wet due to the leak resulting in the reported event.The dsd edge has been designed with fire-resistant materials and any thermal events which occur internal to the unit are expected to be contained and not to travel outside of the unit.Furthermore, the service manual provides the following warning language for the gfi and potential thermal events: "to avoid injury or death from an electrical insulation breakdown within the unit, the gfi (ground fault interrupter) circuit breaker should be checked for proper operation on an annual basis.If during the use of this equipment you see or smell smoke, immediately disconnect the unit from the power supply, discontinue use and call medivators technical support." the aer subject of this report was installed in 2011 making it approximately 11 years old.The technician made the necessary repairs, tested the unit, confirmed it to be operating according to specification, and returned it to service.No additional issues have been reported.

• Brand Name: DSD EDGE AUTOMATED ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE REPROCESSING SYSTEM
• Manufacturer (Section D): MEDIVATORS, INC.; 14605 28th avenue n; plymouth MN 55447
• Manufacturer (Section G): MEDIVATORS, INC.; 14605 28th avenue n; plymouth MN 55447
• Manufacturer Contact: daniel davy ; 9800 59th avenue n; plymouth, MN 55442 ; 4403927453
• MDR Report Key: 14117295
• MDR Text Key: 289325184
• Report Number: 2150060-2022-00023
• Device Sequence Number: 1
• Product Code: FEB
• 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: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• 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: 03/16/2022
• 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