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 04/20/2015

Event Type  No Answer Provided  

Event Description

The user facility reported that after a completed cycle in their v-pro max sterilizer an employee was retrieving an instrument pack and received a burn on her hand; the employee sought medical treatment.Another employee was discarding the wrapping of the instrument pack and obtained a burn on her finger; no medical treatment was sought or administered.

Manufacturer Narrative

A steris service technician inspected the sterilizer and found it to be operating properly.The cycle tape subject of the reported event was reviewed and no issues were noted.The sterilizer was returned to service and no additional issues have been reported.The employees subject of the reported event were not wearing proper ppe, specifically gloves while handling the instrument pack.The operator manual states (pp.1-2), "any visible liquids in the chamber or on the load must be treated as concentrated hydrogen peroxide.Observe all hydrogen peroxide handling precautions." the operator manual further states (6-14), "steris recommends (in accordance with ansi/aami st58, 2005) wearing chemical-resistant gloves when using the sterilization unit." the steris clinical education specialist discussed the proper use and operation of the sterilizer in addition to the importance of wearing proper ppe.

• 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 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: 4785554
• MDR Text Key: 5856642
• Report Number: 3005899764-2015-00037
• 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: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2015
• 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: 04/20/2015
• 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