MAUDE Adverse Event Report: STERIS CORPORATION REVITAL-OX RESERT HIGH LEVEL DISINFECTANT

Model Number	4455AW
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via user facility medwatch report number mw5148516 that their tee (transesophageal echocardiogram) probes that had been reprocessed with revital-ox resert high level disinfectant had an unknown white residue substance around them after multiple days of being stored in a probe cabinet.No report of injury.
Additional Manufacturer Narrative
The instructions for use packet lists storage instructions for revital-ox high level disinfectant."revital-ox resert high level disinfectant should be stored in its original sealed container at controlled room temperature 15 - 30°c (59 -86°f).Do not store in food processing areas.Store in dry, well-ventilated area away from chemicals, direct light, heat or open flame.Do not mix with other cleaning or disinfecting products.The expiration date of the revital-ox resert high level disinfectant is found on the immediate container." the report did not identify the name or location of the user facility of the device in question, therefore, additional information could not be obtained.To date, we have not been informed of this event directly from the user facility.The user facility is unknown.The device could not be returned; therefore, a root cause could not be determined.A follow-up report will be submitted should additional information become available.No additional issues have been reported.

• Brand Name: REVITAL-OX RESERT HIGH LEVEL DISINFECTANT
• Common Device Name: DISINFECTANT
• Manufacturer (Section D): STERIS CORPORATION; 7501 page avenue; st. louis MO 63133
• Manufacturer (Section G): STERIS CORPORATION; 7501 page avenue; st. louis MO 63133
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 18531238
• Report Number: 1937531-2024-00001
• Device Sequence Number: 20527789
• Product Code: MED
• UDI-Device Identifier: 00724995095017
• UDI-Public: 00724995095017
• Combination Product (Y/N): N
• 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): 01/17/2024

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: 4455AW
• Device Catalogue Number: 4455AW
• Device Lot Number: 325722
• 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: 12/18/2023
• Initial Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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