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

Model Number	78400-409
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via user facility medwatch report # (b)(4) that their dsd edge automated endoscopy reprocessor (aer) was displaying the error message "no fluid flow".No report of injury.
Additional Manufacturer Narrative
Following receipt of the user facility medwatch, we performed a review of our records.This review identified that the user facility initially contacted medivators on (b)(6) 2021 and reported that the unit subject of the event was displaying the error message "no fluid flow".A medivators field service engineer contacted the user facility to inspect the dsd edge; we are pending a response from the user facility.The "no fluid flow" error indicates that the unit does not detect fluid flow.The unit operated as designed to alert the user that the unit did not detect fluid flow.The medivators dsd edge user manual includes the necessary instructions for the user to mitigate errors messages, including the "no fluid flow" error message.The user manual states (74), "error messages are displayed on the lcd screen to alert the operator to operational malfunctions and/or operational warnings (see the appendix for message definitions).If none of the solutions correct the problem, or if the problem recurs, contact your customer support." the unit was manufactured in 2012 making it approximately 9 years old and is not under medivators service agreement.The user facility is responsible for all maintenance activities.Medivators evaluated the reported event and determined it does not meet our reporting criteria under 21 cfr part 803.It should be noted that medivators is submitting a medical device report (mdr) solely due to the receipt of the user facility medwatch report which is in accordance with our procedures and policies.A follow-up mdr will be submitted when additional information becomes available.

• Brand Name: DSD EDGE ENDOSCOPE REPROCESSING SYSTEM
• Common Device Name: DSD EDGE 120V
• Manufacturer (Section D): MEDIVATORS INC; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 9800 59th avenue n; plymouth, MN 55442 ; 4403927453
• MDR Report Key: 12847799
• Report Number: 2150060-2021-00026
• Device Sequence Number: 4093813
• Product Code: FEB
• UDI-Device Identifier: 00677964046674
• UDI-Public: 00677964046674
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 11/19/2021

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: 78400-409
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 11/19/2021
• 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