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

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 01/21/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A steris account manager arrived onsite, inspected the v-pro max, and was unable to identify any issue with the unit.No malfunction was identified and the account manager confirmed the unit was operating according to specification.Section 1 of the operator manual for the v-pro max 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.Refer to the vaprox hc sterilant material safety data sheet (msds) for appropriate personal protective equipment (ppe), spill containment and cleanup." also, "when handling hydrogen peroxide, wear appropriate personal protective equipment (ppe) and observe all safety precautions.See vaprox hc sterilant msds, product label and package insert for additional handling information." steris provides a recommendation for handling sterilant cups with the unit: "put on personal protective equipment (ppe); steris recommends (in accordance with ansi/aami st58, 2005) using chemical-resistant gloves when removing or installing sterilant cup." the account manager discussed the importance of wearing ppe and performed in-service training with the user facility about ensuring a load is properly processed to prevent the presence of residual peroxide.

Event Description

The user facility reported an employee sustained a burn on the back of her hand after unloading instruments from a v-pro max sterilizer.The employee was not wearing proper ppe at the time of the reported event.The employee sought medical treatment for the reported burn, received a bandage, and returned to work.No report of procedural delay or cancellation.

• 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 5444273
• MDR Text Key: 38454363
• Report Number: 3005899764-2016-00010
• 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: 02/18/2016

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2016
• Initial Date FDA Received: 02/18/2016
• 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