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

Model Number	1-2-510.003
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the advantage plus endoscope reprocessing system and found that the water line was leaking.The operator manual states, "liquid chemicals and/or chemical vapors may be present; wear ppe." the technician repaired the water line, tested the function and operation of the advantage plus endoscope reprocessing system, confirmed it to be operating to specifications and returned the device to service.The advantage plus endoscope reprocessing system is not under steris service agreement for preventive maintenance activities.The user facility is responsible for all maintenance activities.No additional issues have been reported.
Event or Problem Description
The user facility reported an employee was cleaning up fluid from their advantage plus endoscope reprocessing system drip tray and began to feel lightheaded.The employee sought fresh air.It is unknown if additional medical treatment was sought or administered.

• Brand Name: ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM
• Common Device Name: 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: 24698422
• Report Number: 2150060-2026-00014
• Device Sequence Number: 10176899
• Product Code: FEB
• UDI-Device Identifier: 00677964044755
• UDI-Public: (01)00677964044755(11)240606
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 02/24/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2024
• 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