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

Model Number	78400-409
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility notified medivators technical service of several issues with their medivators dsd edge unit, which occurred over the past 12 months.All issues were reported to occur during the reprocessing of an endoscope.There was no patient involvement at the time of the reported events.Following resolution of the reported events for the facility dsd edge, serial number (b)(4), the user facility additionally submitted the following user facility medwatch reports in november 2021: 2300750000-2021-8012, 2300750000-2021-8013, 2300750000-2021-8014, 2300750000-2021-8015, 2300750000-2021-8016.
Additional Manufacturer Narrative
For each of the reported events, medivators field service engineers (fse) were dispatched for evaluation of the reported issue within three (3) business days of the user facility's initial contact with medivators technical service.During each fse visit, the reported issue or error message was investigated and the necessary service activities were performed.The issue was resolved and the reported unit was tested and confirmed to be operating according to specifications.Upon receipt of the medwatch reports, a medivators fse contacted the customer via phone call to inquire on the status of the unit and confirmed the unit to be operating according to specifications.The reported unit was manufactured on june 24, 2015 and installed at the user facility in july 2015.The unit is not under medivators service agreements; user facility is responsible for performing all maintenance on the unit.Steris evaluated the reported event and determined it does not meet our reporting criteria under 21 cfr part 803.It should be noted that steris is submitting a medical device report solely due to the receipt of the user facility medwatch report which is in accordance with our procedures and policies.No additional issues have been reported.

• Brand Name: DSD EDGE ENDOSCOPE REPROCESSING SYSTEM
• Common Device Name: DSD EDGE 120V
• 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: 13022650
• Report Number: 2150060-2021-00031
• Device Sequence Number: 5127430
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2021

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2015
• 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