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, Thermal (2530)

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

The instruments in the cycle subject of the event were reprocessed prior to use.A steris service technician arrived onsite following the reported event to inspect the sterilizer.The technician inspected the sterilizer and found that the sv4 valve was leaking.The technician replaced the injection cylinder assembly including the sv4 valve, tested the unit, and found it to be operating according to specification.The v-pro max sterilizer operator manual (1-2) states, "danger - chemical injury hazard: any visible liquids in the chamber or on the load must be treated as concentrated hydrogen peroxide.Observe all hydrogen peroxide handling precautions.When handling hydrogen peroxide, wear appropriate personal protective equipment." the employee subject of the event was not wearing proper ppe, specifically gloves, while handling the instrument pack as stated in the operator manual.The operator manual states (pp.6-14), "ansi/aami st58, 2013, recommends using chemical-resistant gloves when using the sterilization unit." in addition, the v-pro max operator manual, (a-1) states, "dry all items thoroughly.Ensure all moisture is removed from all internal parts (including lumens).If not, residual hydrogen peroxide may remain at cycle completion and/or a cycle abort occurs.Only dry items are to be placed in sterilization unit." (b)(4)'s guideline for sterile techniques, guidelines for perioperative practice (b)(4) states, "inspect instrument tray wrappers for integrity and moisture before placing the contents on the sterile field." the steris service technician counseled user facility personnel on the importance of wearing proper ppe, specifically gloves while operating their v-pro max sterilizer.No additional issues have been reported.

Event Description

The user facility reported that an employee experienced a burn while handling an instrument tray that was processed in a v-pro max sterilizer.No procedure delay or cancellation occurred.The employee did not seek medical treatment and returned to work.

• 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 7598709
• MDR Text Key: 111456907
• Report Number: 3005899764-2018-00041
• 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,Followup
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2018
• 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