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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Injury (2348)
Event Date 06/08/2018
Event Type  Malfunction  
Manufacturer Narrative

No report of procedure delays or cancellations. During the time of the reported event, an employee was removing a load from the sterilizer with a transfer carriage when the loading rack became unstable and fell from the transfer carriage. All instruments present on the loading rack were reprocessed prior to use in procedures. A steris service technician arrived onsite to inspect the transfer carriage and loading rack and was informed that facility personnel could not identify which transfer carriage and loading rack were subject of the reported event. Based on the description of the event, and the technician's findings with no issues noted with the transfer carriage and loading rack, it appears that one of the wheels on the loading rack became misaligned with the track on the transfer carriage causing the reported event to occur. The technician tested all transfer carriages and loading racks and could not recreate the reported event. The technician found the units and wheels to be operating according to specifications; however, he proactively replaced all the loading rack's wheels. The units were returned to service. The transfer carriages are not under steris service agreement for maintenance and no additional issues have been reported.

 
Event Description

The user facility reported that an employee injured their shoulder while removing a load from the sterilizer with a 60" transfer carriage. Following the event, the employee sought medical treatment for the reported shoulder pain. The employee has since returned to full work duties.

 
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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 Key7687667
MDR Text Key114413978
Report Number3005899764-2018-00061
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 07/13/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
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 Received06/15/2018
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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