MAUDE Adverse Event Report: MEDIVATORS INC. ADVANTAGE PLUS PASS-THRU

Model Number	1-2-610.003
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit.Through discussion with user facility personnel, the technician learned that the rapicide pa test strips were failing.The technician found that user facility personnel were using expired test strips with their advantage plus pass-thru causing the reported event.The technician tested the unit, confirmed it to be operating according to specification, and returned it to service.The technician counseled user facility personnel on the proper use and operation the advantage plus pass-thru, specifically to not use expired test strips.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported that their advantage plus pass-thru was not working properly.Because the facility had no other available methods of reprocessing devices, procedures were postponed.No report of injury.

• Brand Name: ADVANTAGE PLUS PASS-THRU
• Common Device Name: PASS-THRU
• 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: 24627771
• Report Number: 2150060-2026-00011
• Device Sequence Number: 8852704
• Product Code: FEB
• UDI-Device Identifier: 00677964095832
• UDI-Public: (01)00677964095832(11)171004
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 03/18/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2017
• 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