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

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 04/20/2022

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the sterilizer and found that the chamber interior was filled with debris.This resulted in residual hydrogen peroxide being left in the chamber, resulting in the reported event.The v-pro max sterilizer operator manual includes instructions for routine operator maintenance which includes a weekly chamber cleaning if the chamber is dirty.The operator manual states (8-3), "important: the entire chamber should be wiped down and rinsed following any spills or other soiling.Wash inside of chamber and shelf assembly with a non-linting cloth and distilled or ro water." additionally, the technician was informed that the employees subject of the event were not wearing proper ppe specifically gloves as stated in the operator manual.The operator manual states (6-14), "ansi/aami st58, 2013, recommends using 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." the technician cleaned out debris from the strainer in the vacuum and proactively replaced the valves, tested the unit, confirmed it to be operating according to specification, and returned it to service.The technician counseled the user facility personnel on the proper use and operation of the v-pro max sterilizer, specifically cleaning it on a regular basis, and wearing proper ppe.No additional issues have been reported.

Event Description

The user facility reported two employees experienced a burn on their hand while handling items that were processed in a v-pro max sterilizer.One of the employees self-applied ointment to the burn and the other employee did not seek medical treatment.Both employees returned to work.

Manufacturer Narrative

The device manufacture date in the previous report submitted was entered in error and is incorrect.The correct manufacture date for the v-pro max sterilizer is 18-feb-2016.

• 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 ; 4403927453
• MDR Report Key: 14458389
• MDR Text Key: 300336392
• Report Number: 3005899764-2022-00020
• 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: 05/19/2022

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: 04/20/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 04/20/2022
• Supplement Dates FDA Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2016
• 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