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	Chemical Exposure (2570)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their advantage plus endoscope reprocessing system leaked water and disinfectant.Employees that were exposed to the disinfectant fumes sought medical treatment at the user facility emergency department; however, it is unknown what medical treatment was administered.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event and found that the plastic adaptor fitting was damaged.As the adaptor fitting, that is used for units tubing connection, was damaged, this allowed water and disinfectant to leak from the unit and for the reported event to occur.The technician replaced the adaptor fitting, tested the unit, confirmed it to be operating according to specification, and returned it to service.No additional issues have been reported.

• 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: 24964813
• Report Number: 2150060-2026-00017
• Device Sequence Number: 18757940
• Product Code: FEB
• UDI-Device Identifier: 00677964044755
• UDI-Public: (01)00677964044755(11)231228
• 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): 04/23/2026

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
• Device Catalogue Number: ADV2002
• 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: 03/24/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2023
• 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