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

Medical Device Problem Codes	Fluid/Blood Leak (1250); Insufficient Information (3190)
Health Effect - Clinical Code	Eye Pain (4467)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the sterilizer and found it to be not operational.The user facility was provided with a replacement unit.The unit subject of the event will be returned to steris for evaluation.A follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported smoke emitting from their v-pro max sterilizer.An employee reported eye irritation and sought medical treatment.The user facility did not disclose if medical treatment was administered.
Additional Manufacturer Narrative
The v-pro max sterilizer, subject of the event was returned to steris for evaluation.The evaluation found, that one of the fittings for the tee underneath the reservoir was leaking sterilant.The sterilant leaked onto the sterilizer's components, resulting in the reported event.The tee should be replaced annually in accordance with the v-pro max sterilizer preventive maintenance checklist.The unit was installed in 2015.And is not under steris service agreement for maintenance activities.The user facility is responsible for all maintenance activities.The user facility was provided with a replacement unit.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
• MDR Report Key: 12174513
• Report Number: 3005899764-2021-00041
• Device Sequence Number: 1669474
• Product Code: MLR
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: user facility
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1