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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

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STERIS MEXICO, S. DE R.L. DE C.V. 66" EVOLUTION TRANSFER CARRIAGE Back to Search Results
Device Problem Device Fell (4014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/02/2020
Event Type  Malfunction  
Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the transfer carriage and found the transfer carriage was damaged. The unit was not operational. A replacement unit will be installed. The unit subject of this event will be returned to steris for evaluation. A follow-up mdr will be submitted when additional information becomes available.

 
Event Description

The user facility reported their evolution transfer carriage fell to the ground prior to removing a processed load from the sterilizer. No report of injury.

 
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Brand Name66" EVOLUTION 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 Key10015497
MDR Text Key199555212
Report Number3005899764-2020-00028
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 04/30/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/30/2020
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 Received04/02/2020
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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