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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/28/2020
Event Type  Malfunction  
Manufacturer Narrative

All instruments were reprocessed prior to use. A steris service technician arrived onsite following the reported event to inspect the unit and found that the transfer carriage and docking station was damaged. Due to the damage observed, the transfer carriage and docking station were unable to be tested by the technician. Based on the description of the event, the employee did not properly align the transfer carriage with the sterilizer's docking station causing an inadequate latch of the transfer carriage's front wheels resulting in the reported event. 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. The technician replaced the docking station and ordered a replacement transfer carriage. No additional issues have been reported.

 
Event Description

The user facility reported that while an operator was unloading their sterilizer, the evolution transfer carriage fell to the ground. 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 44060
4403927453
MDR Report Key10583881
MDR Text Key209152581
Report Number3005899764-2020-00058
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 09/24/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/24/2020
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 Received08/28/2020
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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