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

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 04/05/2023

Event Type  malfunction  

Event Description

The user facility reported that two employees obtained "burns" to their skin after coming in contact with packaging that was sterilized in their v-pro max 2 sterilizer.One employee sought and received medical treatment (ointment).The second employee washed their hands with water.The employees returned to work.

Manufacturer Narrative

A service technician from steris's dealer medical supplies de panama arrived onsite to inspect the v-pro max 2 sterilizer and found the unit to be operating properly.No issues with the function or operation of the sterilizer were identified.The technician proactively replaced the sv4, sv5, and sv6 valves, tested the unit, confirmed it to be operating according to specification, and returned the sterilizer to service.The technician was informed that the employees subject of the reported event 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 counseled 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.

• 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 ; 4403927453
• MDR Report Key: 16863191
• MDR Text Key: 314495845
• Report Number: 3005899764-2023-00024
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: PM
• 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: 05/03/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2023
• Initial Date FDA Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2021
• 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