MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. V-PRO 1 PLUS STERILIZER

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 08/18/2023

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the v-pro 1 plus sterilizer and found the unit to be operating properly.No repairs were required and the unit was returned to service.The technician was informed that the employee was not wearing proper ppe, specifically gloves as stated in the operator manual.The v-pro 1 plus sterilizer operator manual states (6-11), "steris recommends (in accordance with ansi/aami st58, 2005) wearing 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 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 1 plus sterilizer.The v-pro 1 plus operator manual states (a-1), "a.Dry all items thoroughly.B.Ensure all moisture is removed from all internal parts (including lumens).C.Only dry items are to be placed in sterilization unit." the technician counseled the user facility on the importance of wearing proper ppe, specifically gloves, while operating their v-pro 1 plus sterilizer.No additional issues have been reported.

Event Description

The user facility reported an employee experienced a burn on their arm while handling items that were processed in their v-pro 1 plus sterilizer.The employee sought medical treatment at the facility's er and returned to work.

• Brand Name: V-PRO 1 PLUS 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: 17759533
• MDR Text Key: 323543471
• Report Number: 3005899764-2023-00047
• 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
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• 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: 08/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2014
• 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