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

Model Number V-PRO MAX

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 05/11/2023

Event Type  malfunction  

Event Description

The user facility reported that an employee obtained a burn on their left hand while handling items that were processed in their v-pro max sterilizer.The employee sought and received medical treatment (ointment).

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the sterilizer and found the unit to be operating according to specification.No issues with the function or operation of the sterilizer were found, and the unit was returned to service.The technician was informed that the employee subject of the event was not wearing proper ppe specifically gloves as stated in the operator manual.The v-pro max sterilizer 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." additionally, user facility personnel should ensure all instruments are properly dry prior to placement in the v-pro max sterilizer.The operator manual states (a-1), "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 technician was informed that facility personnel reviewed the operator manual on the proper use and operation of the v-pro max sterilizer, specifically wearing proper ppe and properly drying instruments before processing.No additional issues have been reported.

• 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: 17078457
• MDR Text Key: 317670702
• Report Number: 3005899764-2023-00028
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 00724995206987
• UDI-Public: 00724995206987
• 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: 06/07/2023

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: V-PRO MAX
• Device Catalogue Number: VP30002101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 05/11/2023
• Supplement Dates FDA Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2016
• 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