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

Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
A steris service technician was performing service on a v-pro max sterilizer which had previously been removed from use and tagged out for repairs.The technician temporarily left the user facility to obtain additional service parts when user facility personnel reported a burning smell began to emit from the unit.No report of injury.
Additional Manufacturer Narrative
Following the reported event, the v-pro max sterilizer was removed from service and sent back to steris for evaluation.Evaluation results determined that when the steris service technician tagged out the v-pro max sterilizer and temporarily left the user facility to obtain additional service parts, he had placed a valve repair kit on top of the outside of the unit.The valve leaked hydrogen peroxide which entered the wiring sleeve tubing, which contained the electrical wires to the vaporizer heater.The hydrogen peroxide then contacted the wire insulation and caused a breakdown of the insulation material.This caused the two wires to contact and short.When the two wires shorted, this caused the wires to overheat and produce the burning smell and smoke that was observed by user facility personnel.Due to the damage that the v-pro max sterilizer sustained, the user facility received a new v-pro max sterilizer.The new v-pro max sterilizer was installed, tested, and confirmed to be operating according to specifications.The steris service technician who was performing service activities during the time of the reported event was counseled on the importance of not placing service parts on top of a device and to ensure the power to the unit is turned off before performing service activities.No additional issues have been reported.

• Brand Name: V-PRO MAX STERILIZER
• Common Device Name: STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 17670012
• Report Number: 3005899764-2023-00042
• Device Sequence Number: 7105054
• Product Code: MLR
• UDI-Device Identifier: 00724995206987
• UDI-Public: 00724995206987
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 08/04/2023; 08/04/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 09/06/2023; 01/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown