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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon notification to steris that an endoscope used on a patient with cjd was reprocessed in their advantage plus endoscope reprocessing system, a steris clinical representative immediately informed the user facility to stop using their unit, the endoscope subject of the event, and any other instruments that had been processed in the unit after the endoscope exposed to cjd had been first processed.Additionally, steris informed the user facility that incineration is recommended as the only unequivocally safe method for dealing with exposure of equipment and instruments to cjd and other prion transmitted diseases.The advantage plus endoscope reprocessing system operator manual states, "the medivators¿ advantage plus¿ automated endoscope reprocessor should not be used for the cleaning or high-level disinfection of endoscopes or related accessories that have been used on patients with known or suspected prion diseases, such as creutzfeldt-jakob disease (cjd) or variant creutzfeldt-jakob disease (vcjd)." the user facility indicated that a bleach cleaning was performed and has elected to continue to use the unit off-label.Steris is not aware of any adverse clinical event associated with this incident and is filing this mdr because the high-level disinfection of devices processed in the advantage plus cannot be guaranteed unless devices are processed in accordance with instructions for processing and use, and continued use could potentially result in serious harm to users or patients.
Event or Problem Description
The user facility reported that they had reprocessed an endoscope that was used on a patient who tested positive for creutzfeldt-jakob disease (cjd) in their advantage plus endoscope reprocessing system.It was reported by the user facility that following reprocessing, this endoscope was subsequently used on another patient.
Additional Manufacturer Narrative
The advantage plus endoscope reprocessing system subject of the reported event is located at a different facility than initially reported.Additionally, user facility personnel subsequently clarified that there was only a "suspected", not confirmed, patient case of creutzfeldt-jakob disease (cjd).

• Brand Name: ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM
• Common Device Name: ADVANTAGE PLUS 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: 22535769
• Report Number: 2150060-2025-00022
• Device Sequence Number: 7487627
• Product Code: FEB
• UDI-Device Identifier: 00677964044755
• UDI-Public: (01)00677964044755(11)180302
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 07/17/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2018
• 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