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

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 02/13/2014

Event Type  No Answer Provided  

Event Description

The user facility reported an employee received burns on her fingers while removing a package from the v-pro 1 plus chamber.The employee went to employee health and was treated for the burns.The employee has since returned to work with no limitations.No procedural delays/cancellations were reported.

Manufacturer Narrative

A steris service technician arrived at the facility, inspected the v-pro 1 plus sterilizer and confirmed the equipment was operating to specification.The reported event could not be duplicated and no repairs to the v-pro 1 plus sterilizer were required.The employee subject of the reported event was not wearing the appropriate ppe as recommended in the v-pro 1 plus operator manual.The operator manual (6-11) states, "unload sterilization unit: steris recommends (in accordance with ansi/aami st58, 2005) wearing chemical -resistant gloves when using the sterilization unit." in addition, the operator manual (1-2) states, "danger - chemical injury hazard: any visible liquids in the chamber must be treated as concentrated hydrogen peroxide.Observe all hydrogen peroxide handling precautions." the steris account manger is scheduled to visit the facility on monday, (b)(4) 2014 in order to provide additional in-service training to the facility staff on proper use of ppe.

• 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, nuevo leon 6719 0; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 6719 0; MX 67190
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 3678869
• MDR Text Key: 19200389
• Report Number: 3005899764-2014-00018
• 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: 03/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2014
• 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: 02/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other