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

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A meditek technician arrived onsite following the reported event to inspect the v-pro max 2 sterilizer and found the unit to be operating properly.Through follow-up with user facility personnel, the technician was informed that the employees were not wearing proper ppe, specifically gloves as stated in the operator manual.The v-pro max 2 sterilizer operator manual states (6-24), "steris recommends (in accordance with ansi/aami st58, 2013) wearing chemical-resistant gloves when using the sterilization unit." the operator manual further states (1-2), "danger - chemical injury hazard: any visible liquids in the chamber or on the load must be treated as concentrated hydrogen peroxide.Observe all hydrogen peroxide handling precautions.When handling hydrogen peroxide, wear appropriate personal protective equipment." additionally, user facility personnel should ensure all instruments are properly dry prior to placement in the v-pro max 2 sterilizer.The v-pro max 2 sterilizer operator manual states (a-1), "a.Dry all items thoroughly.B.Ensure all moisture is removed from all internal parts (including lumens).If not, residual hydrogen peroxide may remain at cycle completion." the technician proactively replaced the sv4 valve, tested the unit, confirmed it to be operating according to specification, and returned it to service.The meditek technician counseled user facility personnel on the proper use and operation of the v-pro max 2 sterilizer, specifically wearing proper ppe and properly drying instruments before processing.No additional issues have been reported.
Event or Problem Description
The user facility reported two employees experienced burns on their hands while handling items that were processed in a v-pro max 2 sterilizer.No medical treatment was sought or administered.

• Brand Name: V-PRO MAX 2 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
• 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 ; 4403927453
• MDR Report Key: 12637440
• Report Number: 3005899764-2021-00054
• Device Sequence Number: 10350909
• Product Code: MLR
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2020
• 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