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

Model Number	1-2-510.003
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and found no issues with the function or operation of the unit.The unit was tested, confirmed to be operating according to specification, and returned to service.While onsite the technician learned from user facility personnel that the employee subject of the reported event did not move their hand out of the way of the lid when the cycle was about to begin, subsequently causing the reported event.Steris offered in-service training on the proper use and operation of the advantage plus endoscope reprocessing system, however the user facility declined.No additional issues have been reported.
Event or Problem Description
The user facility reported that the lid to their advantage plus endoscope reprocessing system contacted an employee's hand.The employee sought medical treatment, however it is unknown if medical treatment was administered.

• 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: 22816594
• Report Number: 2150060-2025-00025
• Device Sequence Number: 8703919
• Product Code: FEB
• UDI-Device Identifier: 00677964044755
• UDI-Public: (01)00677964044755(11)171227
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K082988
• 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): 08/15/2025

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: 07/17/2025
• Initial Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2017
• 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