MAUDE Adverse Event Report: MEDIVATORS INC ADVANTAGE PLUS PASS-THRU; ENDOSCOPE REPROCESSING SYSTEM

Model Number	1-2-610.003
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Eye Irritation (4803)
Date of Event	04/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our investigation into the reported event is in progress.A follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that disinfectant leaked from their advantage plus pass-thru subsequently causing two employees to experience eye irritation.Medical treatment was sought and administered (eye irrigation).

• Brand Name: ADVANTAGE PLUS PASS-THRU
• Common Device Name: ENDOSCOPE REPROCESSING SYSTEM
• Manufacturer (Section D): MEDIVATORS INC; 14605 28th avenue north; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC; 14605 28th avenue north; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 25305670
• Report Number: 2150060-2026-00022
• Device Sequence Number: 15781662
• Product Code: FEB
• UDI-Device Identifier: 00677964095832
• UDI-Public: (01)00677964095832(11)211201
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172677
• 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,Followup
• Report Date (Section B): 05/27/2026

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: 1-2-610.003
• Device Catalogue Number: 12610003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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