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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.
 
Manufacturer Narrative
The unit subject of the event was returned to steris for evaluation and it was determined that the set screws were loose.The root cause of the reported event is attributed to impact damage by facility personnel which allowed the set screws to become loose.The transfer carriage subject of this event has been replaced.User facility personnel were counseled on the proper use and operation of the transfer carriage, including the importance of not bumping the transfer carriage into walls or other equipment.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 Key10583881
MDR Text Key209152581
Report Number3005899764-2020-00058
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 09/24/2020
1 Device was Involved in the Event
1 Patient was 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
Date Manufacturer Received08/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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