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

Device Problem Device Disinfection Or Sterilization Issue (2909)

Patient Problem Skin Discoloration (2074)

Event Date 06/30/2017

Event Type  malfunction  

Manufacturer Narrative

The sterilization cycle completed successfully; the instrument pack was then placed into sterile storage.No delay or cancellation were reported as a result.The instrument present in the v-pro max sterilizer was reprocessed prior to use.Prior to the reported event, user facility personnel utilized a multigate gauge wrap to wrap instruments prior to sterilization.Steris has not validated multigate gauge wraps for v-pro max sterilizers.The v-pro max sterilizer operator manual states (p.A-3), "use only amsco v-pro max low temperature sterilization system compatible polypropylene sterilization wrap (contact steris or your local distributor to identify compatible wraps in your market)"."steris has a full line of tyvek pouches and tubing that has been validated for use in the system compatible polypropylene sterilization wrap".The employee handling the instrument pack observed moisture between the instrument tray and the inside multigate gauge wrap.The employee proceeded to touch the moisture with his finger and a few minutes later noted a burning feeling.The employee subject of the reported event was not wearing proper personnel equipment as stated in the operator manual.The operator manual states (p.6-14), "ansi/aami st58, 2013, recommends using chemical-resistant gloves when using the sterilization unit"."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".The operator manual states, (p.3-2), "failure to thoroughly clean, rinse, and dry articles to be sterilized could result in an ineffective sterilization cycle".Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.

Event Description

The user facility reported an employee obtained a discoloring to their fingers while handling an instrument pack that had been sterilized in a v-pro max sterilizer.The employee did not seek or receive medical treatment.

Manufacturer Narrative

On (b)(6) 2017, a device technologies (b)(6) technician arrived onsite to inspect the v-pro max sterilizer.The dta technician inspected the unit's chamber and observed the unit's valve function was operational.The dta technician counseled user facility personnel on the proper use and operation of the unit.No additional issues have been 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: lyndsey snyder ; 5960 heisley road; mentor, OH 44060 ; 4403927386
• MDR Report Key: 6766731
• MDR Text Key: 82021264
• Report Number: 3005899764-2017-00037
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/05/2017
• 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