MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. V-PRO MAX STERILIZER

Device Problem Use of Device Problem (1670)

Patient Problem Burn, Thermal (2530)

Event Date 07/27/2018

Event Type  malfunction  

Manufacturer Narrative

The instruments in the cycle subject to the event were reprocessed prior to use.A steris service technician arrived onsite following the reported event to inspect the v-pro max sterilizer.The technician inspected the sterilizer and found the unit to be operating properly.No issues with the function or the operation of the sterilizer were identified.While onsite, the technician spoke with user facility personnel who confirmed that the employee was not wearing proper ppe, specifically gloves while operating the v-pro max sterilizer.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 v-pro max operator manual (1-2) states, "ansi/aami st58, 2013, recommends using chemical-resistant gloves when using the sterilization unit." additionally, user facility personnel should ensure all instruments are properly dry prior to placement in the v-pro max sterilizer.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." a steris account manager performed in-service training on the importance of drying instruments and wearing proper ppe, specifically gloves while operating their v-pro max sterilizer.The v-pro max sterilizer was installed in 2016 and is not under steris service agreement.No additional issues have been reported.

Event Description

The user facility reported that an employee experienced a burn while handling items that were processed in a v-pro max sterilizer.No medical treatment was sought or administered.No procedure delays or cancellations were reported.

• 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: 7806917
• MDR Text Key: 118103011
• Report Number: 3005899764-2018-00085
• 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: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2018
• Initial Date FDA Received: 08/22/2018
• 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