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

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 01/04/2024

Event Type  malfunction  

Manufacturer Narrative

Through follow-up with the user facility, steris learned that the employee was 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 v-pro max operator manual (1-2) states, "ansi/aami st58, 2013, recommends using chemical-resistant gloves when using the sterilization unit." additionally, user facility personnel should ensure all instruments are properly dry prior to placement in the v-pro max sterilizer.The v-pro max operator manual, (a-1) states, "dry all items thoroughly.Ensure all moisture is removed from all internal parts (including lumens).If not, residual hydrogen peroxide may remain at cycle completion and/or a cycle abort occurs.Only dry items are to be placed in sterilization unit." the unit is pending inspection.The investigation is in process.A follow-up mdr will be submitted when additional information become available.

Event Description

The user facility reported that an employee received a burn on their hand and fingers while operating a v-pro max sterilizer.No medical treatment was sought and administered.

• Brand Name: V-PRO MAX 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: 18668813
• MDR Text Key: 334972640
• Report Number: 3005899764-2024-00005
• Device Sequence Number: 1
• Product Code: MLR
• 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,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• 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
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2014
• 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