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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 TRANSFER CARRIAGE TO STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 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 03/01/2019
Event Type  Malfunction  
Manufacturer Narrative

The instrument packs present on the loading car did not contact the floor and did not require reprocessing. The technician found that the root cause of the reported event was a misalignment between the lock roller and the rails. Additionally, the technician found that the docking station and loading car were damaged due to the impact. The docking station and loading car were replaced. The technician made the proper adjustments to the lock roller, tested the unit, confirmed it to be operating according to specifications, and returned it to service. No additional issues have been reported.

 
Event Description

The user facility reported that the loading car fell to the floor while unloading the sterilizer with their evolution transfer carriage. No report of injury.

 
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Brand NameEVOLUTION 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 Key8463678
MDR Text Key140610022
Report Number3005899764-2019-00031
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 03/29/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/29/2019
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 Received03/01/2019
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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