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 10/03/2023

Event Type  malfunction  

Manufacturer Narrative

Through follow-up with user facility personnel, the technician was informed that the employee was not wearing proper ppe, specifically gloves as stated in the operator manual.The v-pro max 2 sterilizer operator manual states (6-35), "steris recommends (in accordance with ansi/aami st58, 2013) wearing chemical-resistant gloves when using the sterilization unit." the operator manual further states (1-3), "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." 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-3), "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 inspected the unit and ran a test cycle which failed for "pressure rise high." the technician replaced the injection manifold and manifold valves, tested the unit, confirmed it to be operating according to specification, and returned it to service.The 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 Description

The user facility reported that an employee obtained burns on their hand while handling an instrument that was processed in their v-pro max 2 sterilizer.No medical treatment was sought or administered.The employee washed their hands and returned to work.

• 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
• MDR Report Key: 18047997
• MDR Text Key: 327076544
• Report Number: 3005899764-2023-00057
• 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: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• 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: 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2021
• 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