MAUDE Adverse Event Report: MEDIVATORS, INC. ADVANTAGE PLUS PASS-THRU AUTOMATED ENDOSCOPE REPROCESSOR

Model Number	1-2-610.003
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their advantage plus pass-thru door opened while in-cycle, spraying liquid all over the room.No report of injury.
Additional Manufacturer Narrative
A medivators service technician was dispatched to inspect the unit.The investigation into this event is in process; a follow-up mdr will be submitted when additional information becomes available.
Additional Manufacturer Narrative
A medivators service technician arrived onsite to inspect the unit and found the door would not close.The technician adjusted the magnetic sensors to allow the door to close.The technician performed further testing and was unable to duplicate the report of the door opening during a cycle.The technician performed several repairs to the unit including replacing the main board and reinstalling the software.Following the repairs, the technician tested the unit, confirmed it to be operating according to specification, and returned it to service.A complaint review indicates this to be an isolated event.No additional issues have been reported since the unit was returned to service on november 24, 2022.

• Brand Name: ADVANTAGE PLUS PASS-THRU AUTOMATED ENDOSCOPE REPROCESSOR
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• 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 ; 14605 28th ave n; minneapolis, MN 55447 ; 4403927453
• MDR Report Key: 15550914
• Report Number: 2150060-2022-00041
• Device Sequence Number: 14992154
• Product Code: FEB
• UDI-Device Identifier: 00677964095832
• UDI-Public: 00677964095832
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Followup
• Report Date (Section B): 10/06/2022

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
• Operator of Device: Health Professional
• Device Model Number: 1-2-610.003
• 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: 09/21/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2021
• 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