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 07/21/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The employee who received the burn had the area flushed with water by a doctor present in the o.R.The instruments present during the time of the reported event were reprocessed before use.No procedural delays or cancellations were reported.A steris service technician inspected the sterilizer and found the unit to be operating properly.No issues were noted and the sterilizer was returned to service.The steris service technician stated that the reported event may be attributed to user facility personnel not properly drying instruments before placement into the v-pro max sterilizer.The operator manual states (pp.1-1), "failure to thoroughly clean, rinse and dry articles to be sterilized could result in an ineffective sterilization cycle." the employee who opened the instrument pack was not wearing proper ppe, specifically gloves, during the time of the reported event.The operator manual states (pp.6-29), "steris recommends (in accordance with ansi/aami st58, 2005) wearing chemical-resistant gloves when using the sterilization unit." the steris service technician instructed user facility personnel the importance of wearing proper gloves and thoroughly drying instruments before placement in instrument packs.

Event Description

The user facility reported that an employee removed an instrument pack following a completed v-pro max sterilization cycle and brought the instrument pack to the o.R.Another employee opened the instrument pack without wearing proper ppe and obtained a burn.

• 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: 5886683
• MDR Text Key: 53445198
• Report Number: 3005899764-2016-00056
• 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: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2016
• 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