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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. EVOLUTION STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. EVOLUTION STERILIZER Back to Search Results
Device Problem Device Fell (4014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/10/2019
Event Type  malfunction  
Manufacturer Narrative
While onsite, the technician inspected the sterilizer and found that the top panel was missing the bolts that secure the panel in place. The technician secured the panel in place, tested the unit, confirmed it to be operating according to specification, and returned it to service. The unit was installed at the user facility in september 2019 by a third-party service provider. At the time of installation, the third-party service provider did not install the bolts for the top panel. A steris installation project manager has re-trained the third-party service provider on proper installation of the evolution sterilizer. No additional issues have been reported.
 
Event Description
The user facility reported that while a steris service technician was onsite for service the top panel on their evolution sterilizer fell off the unit. The panel was caught by the technician and a user facility employee. There were no injuries associated with the reported event.
 
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Brand NameEVOLUTION 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 Key9172308
MDR Text Key199550660
Report Number3005899764-2019-00084
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 10/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/09/2019
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 Received09/10/2019
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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