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 06/24/2015

Event Type  No Answer Provided  

Event Description

The user facility reported that after a completed sterilization cycle an employee was removing instruments and obtained a burn.The employee washed his hands with water and returned to work.The user facility removed the sterilizer from service pending inspection from a steris service technician.A procedural cancellation occurred due to the removal of equipment.

Manufacturer Narrative

A steris service technician inspected the sterilizer and found it to be operating properly.The technician reviewed the cycle print out subject of the reported event and no issues were noted.The technician ran test cycles and returned the sterilizer to service.No additional issues have been reported.The operator manual states (pp.2-2), "failure to thoroughly clean, rinse and dry articles to be sterilized could result in an ineffective sterilization cycle." the employee who removed the instrument pack was not wearing proper ppe, specifically gloves.The operator manual states (pp.6-14), "steris recommends (in accordance with ansi/aami st58, 2005) wearing chemical-resistant gloves when using the sterilization unit." the steris technician advised user facility personnel the importance of wearing proper ppe when removing instruments from the sterilizer.

• 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: 4918605
• MDR Text Key: 18882262
• Report Number: 3005899764-2015-00047
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• 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: 06/24/2015
• 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