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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 12/16/2019
Event Type  malfunction  
Manufacturer Narrative
All instruments were reprocessed prior to use.A steris service technician arrived onsite following to reported event to inspect the transfer carriage and found that the lower leg nuts were loose allowing the front wheel assembly of the transfer carriage to become unlocked and the reported event to occur.The loading car and transfer carriage were damaged as a result of the reported event and will be replaced under warranty.
 
Event Description
The user facility reported their evolution transfer carriage fell to the ground while an operator was removing a processed load from the sterilizer.No report of injury.
 
Manufacturer Narrative
The user facility elected to install the replacement evolution transfer carriage and loading car themselves.A steris service technician arrived on site, confirmed that the replacement carriage and loading car were operating according to specifications, and returned them to service.No additional issues have been reported.
 
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Brand Name
EVOLUTION TRANSFER CARRIAGE
Type of Device
TRANSFER CARRIAGE
Manufacturer (Section D)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, 67190
MX  67190
MDR Report Key9591956
MDR Text Key199553538
Report Number3005899764-2020-00003
Device Sequence Number1
Product Code FLE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 01/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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