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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. V-PRO MAX STERILIZER
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STERIS MEXICO, S. DE R.L. DE C.V. V-PRO MAX STERILIZER Back to Search Results
Device Problems Fluid/Blood Leak (1250); Insufficient Information (3190)
Patient Problem Eye Pain (4467)
Event Date 06/17/2021
Event Type  malfunction  
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 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.
 
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.
 
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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, 67190
MX  67190
MDR Report Key12174513
MDR Text Key262975540
Report Number3005899764-2021-00041
Device Sequence Number1
Product Code MLR
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 07/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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