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

Model Number	1-2-510.003
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the event is currently in progress.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that while an employee was preparing to reprocess an endoscope, the door of their advantage plus endoscope reprocessing system contacted their hands.The employee experienced redness on their hands however, no medical treatment was sought or administered.
Additional Manufacturer Narrative
A steris service technician arrived on-site to inspect the unit.The reported event could not be duplicated.The unit was confirmed to be operating according to specification and returned to service.No repairs were made.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: 25035470
• Report Number: 2150060-2026-00018
• Device Sequence Number: 10261343
• Product Code: FEB
• UDI-Device Identifier: 00677964044755
• UDI-Public: (01)00677964044755(11)201023
• Combination Product (Y/N): N
• Initial Reporter Country: EN
• PMA/510(K) Number: K102996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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: ADV2006
• 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: 04/14/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2020
• 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