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 07/22/2015

Event Type  No Answer Provided  

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 was unable to duplicate the reported event.The technician ran test cycles and returned the sterilizer to service.No additional issues have been reported.The operator manual states (pp.6-3), "all items must be thoroughly cleaned, rinsed and dried before loading into the sterilization unit.Carefully inspect all instruments and devices for cleanliness, dryness, flaws and damage prior to packaging.If visual soil or moisture is present, clean and dry load again.If any damage is discovered, item must be replaced or repaired before using." 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 technician discussed the proper use and operation of the sterilizer with user facility personnel.

Event Description

The user facility reported that an employee was removing an instrument pack after a completed v-pro max sterilization cycle and obtained a burn.No medical treatment was sought or administered.

• 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: 5014661
• MDR Text Key: 23458043
• Report Number: 3005899764-2015-00054
• 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
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2015
• 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: 07/22/2015
• 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