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

Model Number	1-2-510.003
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their air compressor to their advantage plus endoscope reprocessing system was damaged subsequently causing procedures to be postponed.No report of injury.
Additional Manufacturer Narrative
The air compressor delivers proper air flow and pressure for correct system operation.No issues were noted with the function or operation of the advantage plus endoscope reprocessing system.The advantage plus was installed in 2022 and is not under steris service agreement for maintenance activities; the user facility is responsible for all maintenance activities.The air compressor subject of the reported event was replaced by the user facility and the advantage plus endoscope reprocessing system and the air compressor were returned to service.

• Brand Name: ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM
• Common Device Name: ENDOSCOPE REPROCESSING SYSTEM
• 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 ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 23438888
• Report Number: 2150060-2025-00033
• Device Sequence Number: 8533842
• Product Code: FEB
• UDI-Device Identifier: 00677964044755
• UDI-Public: (01)00677964044755(11)220311
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K102996
• 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): 10/31/2025

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: 1-2-510.003
• 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: 10/03/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2022
• 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