MAUDE Adverse Event Report: MEDIVATORS INC. RAPICIDE HIGH LEVEL DISINFECTANT AND STERILANT

Model Number	ML02-0059
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris account manager contacted the user facility and it was reported that the event occurred during normal use.It is unknown what ppe the employee was wearing at the time of the event.The rapicide high-level disinfectant safety data sheet states, "avoid breathing dust/fume/gas/mist/vapours/spray.Use only outdoors or in a well-ventilated area.Wash hands thoroughly after handling.Wear protective gloves/eye protection/face protection.In case of inadequate ventilation wear respiratory protection.Contaminated work clothing must not be allowed out of the workplace.If inhaled: remove person to fresh air and keep comfortable for breathing." the sds further states, "in case of insufficient ventilation, wear suitable respiratory equipment.Respirator selection must be based on known or anticipated exposure levels, the hazards of the product and the safe working limits of the selected respirator." there have been no other complaints associated with this lot.No additional issues have been reported.
Event or Problem Description
The user facility reported that while changing out the bottle of rapicide high-level disinfectant to their dsd 201 automated endoscope reprocessor, an employee was "exposed" to rapicide high-level disinfectant and experienced inhalation/irritation.Medical treatment was sought and administered.

• Brand Name: RAPICIDE HIGH LEVEL DISINFECTANT AND STERILANT
• Common Device Name: DISINFECTANT
• 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: 24095325
• Report Number: 2150060-2026-00004
• Device Sequence Number: 10468754
• Product Code: MED
• UDI-Device Identifier: 00677964034855
• UDI-Public: (01)00677964034855(11)250714(17)270112(10)665525
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K993042
• 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): 01/16/2026

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: ML02-0059
• Device Lot Number: (10)665525
• 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: 12/19/2025
• Initial Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2025
• 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