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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 09/04/2019
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite to inspect the transfer carriage and found the set screws for the roller baring assembly of the transfer carriage were missing. The set screws keep the roller bearing assembly in the proper position to move the front leg and caster assembly along the guide rails. As the roller bearing assembly was not properly positioned, the front leg and caster assembly was able to become unlocked resulting in the reported event. The root cause of the reported event is attributed to impact damage by user facility personnel subsequently allowing the set screws to become loose and detach from the carriage. The carriage and loading car were damaged as a result of the reported event and removed from service. The technician installed a new transfer carriage and loading car. The technician counseled facility personnel on the proper use and operation of the transfer carriage. No additional issues have been reported.
 
Event Description
The user facility reported that an employee was unloading instruments with their evolution transfer carriage when the carriage became unstable resulting in the loading car and carriage to fall to the floor. 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 Key9147288
MDR Text Key196104878
Report Number3005899764-2019-00083
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 10/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received09/04/2019
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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