MAUDE Adverse Event Report: MEDIVATORS INC RAPICIDE PA HIGH LEVEL DISINFECTANT

Model Number	ML020117
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rapicide pa high level disinfectant lot number 593114 expired on november 13, 2023 and was reported to be used by the facility from november 27-29, 2023.User facility personnel should have checked the expiration date on the rapicide prior to use as part of their daily startup.The dsd edge endoscope reprocessing system states the following as part of daily startup (31), "check disinfectant containers.2.Check the expiration date of part a and part b.If either dates are in the past, replace both containers." the user facility reported that the peracetic acid concentration was tested after each disinfection cycle with rapicide pa test strips to ensure that it is above minimum recommended concentration as stated in the instructions for use and that the test strips indicated passing results.Devices processed in a dsd edge endoscope reprocessing system cannot be guarantee as high-level disinfected or patient ready unless devices are processed in accordance with medivators instructions for processing and use.No additional issues have been reported.
Event or Problem Description
The user facility reported that they were using an expired bottle of rapicide pa high level disinfectant for approximately two days while processing instruments in their dsd edge endoscope reprocessing system.No report of injury.

• Brand Name: RAPICIDE PA HIGH LEVEL DISINFECTANT
• Common Device Name: DISINFECTANT
• Manufacturer (Section D): MEDIVATORS INC; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 14605 28th ave north; minneapolis, MN 55447 ; 4403927453
• MDR Report Key: 18946590
• Report Number: 2150060-2024-00021
• Device Sequence Number: 12775394
• Product Code: FEB
• UDI-Device Identifier: 00677964063619
• UDI-Public: 00677964063619
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 03/20/2024

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: ML020117
• Device Catalogue Number: ML020117
• Device Lot Number: 593114
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 03/20/2024
• Date Device Manufactured: 08/01/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown