MAUDE Adverse Event Report: Medivators Inc Advantage Plus Endoscope Reprocessing System

Model Number	1-2-510-0002
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported via vigilance report that the incorrect detergent was utilized within their advantage plus automated endoscope reprocessor to process endoscopes.The endoscopes were subsequently used during patient procedures.No report of injury.

• Brand Name: Advantage Plus Endoscope Reprocessing System
• 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 ; +1(440)259-7401
• MDR Report Key: 50097949
• Report Number: 2150060-2026-00030
• Device Sequence Number: 21424693
• Product Code: FEB
• UDI-Device Identifier: 00677964044755
• UDI-Public: (01)00677964044755(11)240715
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 07/31/2026

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: 1-2-510-0002
• 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: 07/20/2026
• Initial Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2024
• 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