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 02/19/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A steris service technician arrived onsite and reviewed the cycle printout subject of the reported event.The cycle printout confirmed the cycle completed successfully with no alarms or aborts.The technician noted the cycle printout included a message which read "load test repeated".This message suggests that moisture is present in the load.The operator manual states (pp.1-3), "failure to thoroughly clean, rinse and dry articles to be sterilized could result in an ineffective sterilization cycle." the technician inspected the unit and found it to be operating properly; no issues were noted.The employee was not wearing proper ppe during the time of the reported event, specifically gloves.Additionally, pp.6-29 states, "unload sterilization unit- steris recommends (in accordance with ansi/aami st58, 2005) wearing chemical-resistant gloves when using the sterilization unit." while onsite, the technician discussed the importance of wearing proper ppe and the proper use and operation of the sterilizer.

Event Description

The user facility reported an employee obtained a burn while handling items which were removed from v-pro max sterilizer.The employee rinsed the affected area with water and did not seek medical attention.

• 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: 5510515
• MDR Text Key: 40676470
• Report Number: 3005899764-2016-00025
• 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: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• 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: 02/19/2016
• 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