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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. 60" TRANSFER CARRIAGE TRANSFER CARRIAGE TO STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 60" TRANSFER CARRIAGE TRANSFER CARRIAGE TO STERILIZER Back to Search Results
Device Problem Device Tipped Over (2589)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/19/2018
Event Type  Malfunction  
Manufacturer Narrative

The user facility stated they were transferring a processed load when the rear left swivel wheel detached causing the cart to tip over and instruments to fall to the floor. All instruments affected were reprocessed prior to use in patient procedures. A steris service technician arrived on-site, inspected the cart, and identified the swivel caster wheel and the rubber gasket used to lock the wheel required replacement. The technician found that the swivel caster wheel and rubber gasket had become worn due to improper maintenance of the cart. The 60" transfer cart has been in use at the user facility since 2003 and is not under steris contract for maintenance services. The technician replaced the swivel caster wheel assembly, tested the unit, and confirmed it to be operating according to specification. The technician notified the user facility of the proper preventive maintenance practices required when using the 60" transfer cart. No additional issues have been reported.

 
Event Description

The user facility reported their 60" transfer carriage tipped over when transferring a load after a processing cycle. No injury, procedure delay, or cancellation was reported.

 
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Brand Name60" TRANSFER CARRIAGE
Type of DeviceTRANSFER CARRIAGE TO STERILIZER
Manufacturer (Section D)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, nuevo leon 67190
MX 67190
Manufacturer (Section G)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, nuevo leon 67190
MX 67190
Manufacturer Contact
daniel davy
5960 heisley road
mentor, OH 44060
4403927453
MDR Report Key7275087
MDR Text Key100448066
Report Number3005899764-2018-00012
Device Sequence Number1
Product Code FLE
Combination Product (Y/N)N
Reporter Country CodeCA
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 02/15/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/15/2018
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? No
Event Location No Information
Date Manufacturer Received01/19/2018
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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