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	Eye Irritation (4803)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported an odor emitting from their advantage plus endoscope reprocessing system.Employees present experienced vomiting, headaches, neck pain and stinging eyes.The employees sought and received medical treatment.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event and found rapicide part a to be leaking from one of the dosing pumps and reservoirs.The operator manual states, "liquid chemicals and/or chemical vapors may be present; wear ppe." user facility personnel stated that the employees subject of the reported event were wearing proper personal protective equipment (ppe) while in the room.The technician replaced the dosing pump and reservoirs, tested the function and operation of the device, confirmed it to be operating specifications and returned it to service.No additional issues have been reported.

• 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: 24698421
• Report Number: 2150060-2026-00013
• Device Sequence Number: 10176898
• Product Code: FEB
• UDI-Device Identifier: 00677964044755
• UDI-Public: (01)00677964044755(11)201116
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: 11/16/2020
• 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