MAUDE Adverse Event Report: MEDIVATORS, INC. ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM

Model Number	EGA-500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the unit and found that the connectors and o-ring on one of the water filters were broken.The technician replaced the connectors and o-ring on the filter, tested the unit, confirmed it to be operating according to specification, and returned it to service.No additional issues have been reported.
Event or Problem Description
The user facility reported that their advantage plus endoscope reprocessing system was leaking water onto the floor.No report of injury.

• Brand Name: ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM
• Common Device Name: ENDOSCOPE REPROCESSING SYSTEM
• 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: 15349270
• Report Number: 2150060-2022-00035
• Device Sequence Number: 5227346
• Product Code: FEB
• UDI-Device Identifier: 00677964063664
• UDI-Public: 00677964063664
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2022

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: EGA-500
• 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: 08/04/2022
• Initial Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2018
• 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