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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 Consequences Or Impact To Patient (2199)
Event Date 01/03/2020
Event Type  Malfunction  
Manufacturer Narrative

A steris service technician arrived onsite following to reported event to inspect the transfer carriage and found that the height of the transfer carriage's locking pins were not properly aligned with the sterilizer's docking station. While onsite, the technician spoke with user facility personnel and learned the carriage was being used with multiple sterilizers. During installation, the transfer carriage locking mechanism to the docking station is adjusted to a specific individual sterilizer. Utilizing with multiple sterilizers of various heights contributed to the misalignment of the transfer carriage to the docking station. The technician raised the locking pins 3/8 inch in order to secure the carriage. The technician tested the unit, confirmed it to be operating according to specification, and returned it to service. The technician counseled facility personnel on the proper use and operation of the evolution transfer carriage, specifically utilizing the carriage with the appropriate sterilizer. 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 Key9616116
MDR Text Key199553804
Report Number3005899764-2020-00007
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 01/22/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/22/2020
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 Received01/03/2020
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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