MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. V-PRO MAX 2 STERILIZER

Device Problem Leak/Splash (1354)

Patient Problem Headache (1880)

Event Date 12/12/2023

Event Type  malfunction  

Event Description

The user facility reported that 8 employees experienced headaches while a cycle was in process for their v-pro max 2 sterilizer.The employees were sent to the facility's er.No medical treatment was administered, and all employees returned to work.

Manufacturer Narrative

A steris service technician inspected the v-pro max 2 sterilizer and found the air mist eliminator to be saturated with oil.The technician further inspected the unit and found the umbrella check valve was dislodged subsequently allowing the filters in the air mist eliminator to become saturated with oil.The vacuum pump oil is non-toxic and not considered hazardous.The steris technician replaced the filters within the air mist eliminator, the o-rings and umbrella check valve and oil in the unit's reservoir.The technician ran a test cycle, confirmed the unit to be operating to specifications and returned it to service.No additional issues have been reported.

• Brand Name: V-PRO MAX 2 STERILIZER
• Type of Device: STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 18500054
• MDR Text Key: 333111727
• Report Number: 3005899764-2024-00003
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 00724995158354
• UDI-Public: 00724995158354
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1