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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. 66" EVOLUTION STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 66" EVOLUTION STERILIZER Back to Search Results
Device Problems Detachment Of Device Component (1104); Component Falling (1105)
Patient Problem Injury (2348)
Event Date 03/20/2018
Event Type  Malfunction  
Manufacturer Narrative

During the time of the reported event, an employee was unloading the sterilizer when the top panel of the sterilizer completely detached contacting the employee. A steris service technician arrived onsite to inspect the evolution sterilizer and found that the top panel was missing the two bolts that secure the panel in place. The technician adjusted the top panel and secured it in place. The technician tested the unit and found it to be operating according to specification. The unit was installed in 2016 and is under steris service contract agreement. The steris district service manager has counseled his team to ensure all bolts are secured in place following all service activities and to prevent this event from recurring. No additional issues have been reported.

 
Event Description

The user facility reported that the top panel located on their 66" evolution sterilizer fell off the unit injuring an employee. The employee sought medical treatment and was cleared to return to work. No report of procedure delay or cancellation.

 
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Brand Name66" EVOLUTION STERILIZER
Type of DeviceSTERILIZER
Manufacturer (Section D)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, nuevo leon 67190
MX 67190
Manufacturer (Section G)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, nuevo leon 67190
MX 67190
Manufacturer Contact
daniel davy
5960 heisley road
mentor, OH 44060
4403927453
MDR Report Key7440978
MDR Text Key106021796
Report Number3005899764-2018-00021
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 04/18/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/18/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/21/2018
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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