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 05/19/2023

Event Type  malfunction  

Event Description

The user facility reported that an employee obtained a burn to their hand while handling an instrument pack that was sterilized in their v-pro max 2 sterilizer.The employee sought and received medical treatment.

Manufacturer Narrative

A steris service technician arrived on site to inspect the v-pro max 2 sterilizer and found it to be operating properly.No issues with the function or operation of the sterilizer were identified.The technician was informed that the instrument pack had been processed in the sterilizer and then placed on a drying rack in the surgical room.Prior to the start of a procedure, a nurse identified liquid on the outside of the instrument pack, the liquid then made contact with the nurse's hand resulting in the reported event.The v-pro max 2 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." 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, (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 account manager will provide in-service training to facility personnel on the proper use of handling of instrument packs, specifically ensuring all instruments are properly dried prior to processing.No additional issues have been reported.

Manufacturer Narrative

The account manager offered in-service training on the proper use of handling instrument packs, specifically ensuring all instruments are properly dried prior to processing.The customer declined in-service training.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
• MDR Report Key: 17144767
• MDR Text Key: 317337834
• Report Number: 3005899764-2023-00029
• 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,Followup
• Report Date: 06/16/2023

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: 05/19/2023
• Initial Date FDA Received: 06/16/2023
• Supplement Dates Manufacturer Received: 05/19/2023
• Supplement Dates FDA Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2021
• 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