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

Model Number	1-2-510.003
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite and found the air compressor to the advantage plus endoscope reprocessing system had been plugged in utilizing a non-steris extension cord not provided by steris.While onsite the technician inspected the advantage plus endoscope reprocessing system replaced the compressor and power cord, tested the unit, confirmed it to be operating according to specification, and returned it to service.The advantage plus endoscope reprocessing system operator manual states, "7.1 using incorrect power cords may damage the automated endoscope reprocessor; only use power cords that are provided by steris." additionally, the advantage plus endoscope reprocessing system site requirements states for power supply, "a gfi protected outlet (nema 5-15r) should be located within the operator's reach." the technician counseled user facility personnel on the proper use and operation of the advantage plus endoscope reprocessing system, specifically, correct use of power cords.A 3-year complaint review confirmed this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported an employee burned their hand and "got shocked" while plugging in the air compressor to their advantage plus endoscope reprocessing system.Additionally, the user facility stated, "the cable was possibly exposed to moisture".Out of caution, the employee sought an ekg test following the reported event; however, the results are unknown.

• 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: 22797873
• Report Number: 2150060-2025-00024
• Device Sequence Number: 18214434
• Product Code: FEB
• UDI-Device Identifier: 00677964044755
• UDI-Public: (01)00677964044755(11)230412
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 08/13/2025

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: 07/14/2025
• Initial Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2023
• 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