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

Model Number max 2

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 03/06/2023

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the v-pro max 2 sterilizer and found the unit to be operating properly.No issue with the function or operation of the sterilizer was identified and the sterilizer was returned to service.Based on the description of the event, the bi was likely damaged prior to the cycle allowing hydrogen peroxide to become trapped and remain after the cycle subsequently causing the reported event to occur.The bi media is water based and non-toxic.The reported burn is attributed to the employee not wearing proper ppe, specifically gloves, while operating their v-pro max sterilizer.The v-pro max sterilizer operator manual 1-2 states, 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.The technician counseled user facility personnel on the importance of wearing proper ppe, specifically gloves, while operating their v-pro max sterilizer.No additional issues have been reported.

Event Description

The user facility reported that while an employee was removing a biological indicator bi from their v-pro max 2 sterilizer they experienced a burn.No medical treatment was sought or administered.The employee rinsed their hand with water and continued working.

• 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: 16657866
• MDR Text Key: 312782115
• Report Number: 3005899764-2023-00017
• 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: 03/31/2023

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
• Device Model Number: max 2
• Device Catalogue Number: VP50002101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2020
• 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