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

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 10/16/2017

Event Type  malfunction  

Manufacturer Narrative

The employee subject of the reported event sought and received medical treatment and returned to work.The employee was not wearing the required ppe at the time of the reported event.The user facility stated that the v-pro max sterilizer was operating properly.Th e steris operator manual states on page 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.Refer to the vaprox hc sterilant safety data sheet (sds) for appropriate personal protective equipment (ppe; refer to section 2, terms, definitions and symbols), spill containment and cleanup." and on page 6-14, "steris recommends (in accordance with ansi/aami st58, 2005) wearing chemical-resistant gloves when using the sterilization unit".A steris account manager notified the user facility of the appropriate ppe required when using the v-pro max sterilizer.No additional issues have been reported.

Event Description

The user facility reported an employee experienced a burn when unloading their v-pro max sterilizer.No procedure delay or cancellation was 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, nuevo leon 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 7002705
• MDR Text Key: 92478174
• Report Number: 3005899764-2017-00058
• 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: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: No
• 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