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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 Laceration(s) (1946)
Event Date 05/20/2019
Event Type  Malfunction  
Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the evolution sterilizer. The technician was informed that the employee was putting a load into the sterilizer when the top panel fell causing the employee to cut their finger as they tried to catch it. The technician inspected the unit and found that the screws that hold the top panel in place had never been installed, as they were found to be sitting on top of the unit. This allowed the panel to fall and the reported event to occur. The panel was secured with the screws, and the technician confirmed the unit to be operating according to specification. The washer was returned to service. Steris will conduct re-training with the technician who performed installation. No additional issues have been reported.

 
Event Description

The user facility reported the top panel of their evolution sterilizer fell causing an employee to cut their finger. Medical treatment was sought and administered.

 
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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 Key8713872
MDR Text Key152040323
Report Number3005899764-2019-00061
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 06/19/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/19/2019
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 Received05/21/2019
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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