MAUDE Adverse Event Report: MEDIVATORS, INC. DSD EDGE ENDOSCOPE REPROCESSING SYSTEM; DSD EDGE 120 V

Model Number	78400-402
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported that their display panel on their dsd edge endoscope reprocessing system was not functioning and detergent appeared to be leaking in the unit.Medivators technical service advised the customer to unplug the unit from the wall and dispatched a medivators field service engineer to go on-site to evaluate the unit.No patient or user harm was reported as a result of this event.
Additional Manufacturer Narrative
A user facility contacted medivators regarding the display panel of their dsd edge endoscope reprocessing system.During troubleshooting with the medivators technical service representative (tsr), it was identified that detergent was leaking within the unit.The medivators tsr advised the user facility to unplug the unit and dispatched a medivators field service engineer (fse) to go on-site to evaluate the unit.The following day, the fse arrived on site and identified a burning smell and the ground fault interruptor covered in black matter.The user facility explained that the previous day, following the medivators tsr instruction to unplug the unit, the facility continued to operate it.During operation, a pop sound occurred, and a spark and smoke was observed.The fire department was called, and the unit was removed from service.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 manufactured in february 2011 making it over 10 years old.No patient or user harm was reported as a result of this event.Due to the condition of the unit, the root cause of the situation could not be confirmed.The user facility has ordered a new endoscope reprocessing system as replacement.

• Brand Name: DSD EDGE ENDOSCOPE REPROCESSING SYSTEM
• Common Device Name: DSD EDGE 120 V
• Manufacturer (Section D): MEDIVATORS, INC.; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS, INC.; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 9800 59th avenue n; plymouth, MN 55442
• MDR Report Key: 12968029
• Report Number: 2150060-2021-00028
• Device Sequence Number: 17256220
• Product Code: FEB
• UDI-Device Identifier: 00677964046674
• UDI-Public: 00677964046674
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K092387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 78400-402
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown