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

Model Number	1-2-510.003
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There are three serial numbers associated with the reported event: (b)(6).Investigation of the reported event is in progress.A follow-up report wil be submitted once additional information becomes available.
Event or Problem Description
The user facility contacted steris requesting functional testing for three of their advantage plus endoscope reprocessing systems following reports of "residue" being observed in the units.The units were removed from service resulting in procedure postponements.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the units and found signs of contamination in the prefilter assemblies.The root cause of the reported event is likely attributed to improper cleaning practices by user facility personnel.The technician replaced the prefilter assemblies.The units were tested, confirmed to be operating according to specification, and returned to service.The advantage plus endoscope reprocessing system operator manual (pg.52) states, "facilities should monitor simethicone usage and ensure timely pre-cleaning, manual cleaning, and reprocessing." while onsite the technician counseled user facility personnel on the proper use and operation of the advantage plus endoscope reprocessing system, specifically on properly cleaning the units.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
• MDR Report Key: 22117378
• Report Number: 2150060-2025-00016
• Device Sequence Number: 14496119
• Product Code: FEB
• UDI-Device Identifier: 00677964044755
• UDI-Public: (01)00677964044755(11)180628
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• 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): 05/30/2025

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: 05/02/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2018
• 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