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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 TRANSFER CARRIAGE

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STERIS MEXICO, S. DE R.L. DE C.V. EVOLUTION TRANSFER CARRIAGE Back to Search Results
Device Problem Device Fell (4014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/07/2020
Event Type  Malfunction  
Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the unit and found the transfer carriage and docking station were damaged. Due to the damage, of both the transfer carriage and docking station the technician was unable to test the functionality of the transfer carriage. The technician counseled user facility personnel on the proper use and operation of the evolution transfer carriage, specifically properly engaging the transfer carriage with the docking station. Due to the damage, the transfer carriage and docking station were replaced. Based on the description of the event, it is likely that the employee did not confirm that the transfer carriage was appropriately aligned with the sterilizer's docking station. No additional issues have been reported.

 
Event Description

The user facility reported their evolution transfer carriage fell to the ground when being removed from the sterilizer. No report of injury.

 
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Brand NameEVOLUTION TRANSFER CARRIAGE
Type of DeviceTRANSFER CARRIAGE
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 Key10372611
MDR Text Key214790898
Report Number3005899764-2020-00050
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 08/06/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/06/2020
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 Received07/07/2020
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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