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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 TRANSFER CARRIAGE STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 66" EVOLUTION TRANSFER CARRIAGE STERILIZER Back to Search Results
Device Problem Device Fell (4014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/19/2019
Event Type  Malfunction  
Manufacturer Narrative

All instruments subject of the event were reprocessed prior to use. A steris service technician arrived onsite to inspect the transfer carriage and found no issue with the function or operation of the transfer carriage. The reported event could not be duplicated; no repairs were required, and the carriage was returned to service. While onsite, through interview with user facility personnel the technician determined that the employee had not fully engaged the transfer carriage to the docking station prior to unloading instruments causing the loading car to fall to the floor. The technician counseled user facility personnel on the proper use and operation of their 66" evolution transfer carriage. No additional issues have been reported.

 
Event Description

The user facility reported that an employee was unloading instruments with their 66" evolution transfer carriage when the loading car became unstable and fell to the floor. No report of injury.

 
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Brand Name66" EVOLUTION TRANSFER CARRIAGE
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 Key8612457
MDR Text Key145278754
Report Number3005899764-2019-00049
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 05/15/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/15/2019
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?
Event Location No Information
Date Manufacturer Received04/19/2019
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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