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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. 42" EVOLUTION STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 42" EVOLUTION STERILIZER Back to Search Results
Device Problem Leak/Splash (1354)
Patient Problem Burn, Thermal (2530)
Event Date 04/10/2019
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite to inspect the sterilizer. While onsite, the technician was informed that the employee had attempted to push the door seal in, and hot water condensate sprayed onto his arm. The evolution sterilizer operator manual states (1-2), "warning - burn hazard: allow sterilizer and accessories to cool to room temperature before performing any cleaning or maintenance procedures. " the technician found that the air manifold was not operating properly subsequently causing the v37 valve to not open to retract the seal. The technician replaced the v37 valve, tested the unit, confirmed it to be operating according to specification, and returned it to service. No additional issues have been reported.
 
Event Description
The user facility reported that their 42" evolution sterilizer was leaking water which burned an employee's arm and alarming "too long to unseal". No medical treatment was sought or administered.
 
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Brand Name42" EVOLUTION STERILIZER
Type of DeviceSTERILIZER
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
4403927453
MDR Report Key8600229
MDR Text Key145020802
Report Number3005899764-2019-00048
Device Sequence Number1
Product Code FLE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/10/2019
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

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