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

Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the sterilizer and found the unit to be operating according to specification.No repairs were required, and the unit was returned to service.Upon arrival, the user facility informed the technician that the employee was not wearing proper ppe, specifically protective eyewear at the time of the reported event.The v-pro max sterilizer operator manual states (i), "all personnel involved in the use and maintenance of this equipment must carefully review and comply with the safety precautions and instructions contained in this manual and the vaprox hc sterilant safety data sheet (sds), product label and package insert." the vaprox hc sterilant safety data sheet states (pg.4), "wear protective eyewear." the v-pro max sterilizer operator manual further states (3-2), "steris recommends (in accordance with aami st58, 2013) the room containing the sterilization unit has a ventilation system capable of an air exchange at least 10 times per hour." the technician counseled user facility personnel on wearing proper ppe when operating the v-pro max sterilizer, specifically wearing protective eyewear.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee experienced eye irritation and dizziness while operating their v-pro max sterilizer.The employee flushed their eyes out with water.

• Brand Name: V-PRO MAX STERILIZER
• Common Device Name: STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• MDR Report Key: 12174394
• Report Number: 3005899764-2021-00040
• Device Sequence Number: 1534224
• Product Code: MLR
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Type of Report: Initial
• Report Date (Section B): 07/15/2021

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1