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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. 54" EVOLUTION STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 54" EVOLUTION STERILIZER Back to Search Results
Device Problem Device Fell (4014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/06/2020
Event Type  Malfunction  
Manufacturer Narrative

All instruments were reprocessed prior to use. A steris service technician arrived onsite to inspect the 54" evolution sterilizer. Upon inspection, the technician found that the docking station was damaged, preventing the transfer carriage from latching properly and the reported event to occur. To resolve the issue, the technician repaired the docking station, tested the unit and confirmed it to be operating according to specifications. The unit was returned to service. The technician counseled the user facility on the proper use and operation of the docking station and transfer carriage, including to exercise proper care when operating the transfer carriage, to not cause damage the docking station. No additional issues have been reported.

 
Event Description

The user facility reported that while an operator was unloading their 54" evolution sterilizer, the transfer carriage fell to the ground. No report of injury.

 
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Brand Name54" 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 
3927453
MDR Report Key9922555
MDR Text Key199554678
Report Number3005899764-2020-00021
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 04/03/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/03/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received03/06/2020
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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