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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 TRANSFER CARRIAGE TO STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 66" EVOLUTION TRANSFER CARRIAGE TRANSFER CARRIAGE TO STERILIZER Back to Search Results
Device Problem Device Fell (4014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/16/2018
Event Type  Malfunction  
Manufacturer Narrative

A steris service technician arrived to inspect the transfer carriage following the reported event. The technician was informed that after placing the load into the sterilizer the transfer carriage fell onto the docking station; causing the frame of the transfer carriage and docking station to become damaged. The technician was unable to test functionality of the transfer carriage as it became damaged due to the reported event. 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. The 66" transfer carriage operator manual states (pg. 1-2), "ensure docking base is properly aligned to allow correct entry of loading car into chamber before permanently fastening base to floor. ". The transfer carriage was removed from service following the reported event and repairs are pending with the customer. While on-site the technician counseled the user facility on the proper procedure for loading and unloading the sterilizer. No additional issues have been reported.

 
Event Description

The user facility reported that their evolution transfer carriage fell onto the docking station after placing a load into the sterilizer. No injury was reported.

 
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Brand Name66" EVOLUTION TRANSFER CARRIAGE
Type of DeviceTRANSFER CARRIAGE TO STERILIZER
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 Key8157431
MDR Text Key130479394
Report Number3005899764-2018-00108
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,Followup
Report Date 12/12/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/12/2018
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?
Event Location No Information
Date Manufacturer Received11/16/2018
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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