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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. 66" EVOLUTION TRANSFER CARRIAGE; TRANSFER CARRIAGE TO STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 66" EVOLUTION TRANSFER CARRIAGE; TRANSFER CARRIAGE TO STERILIZER Back to Search Results
Event Date 10/26/2015
Event Type  No Answer Provided  
Manufacturer Narrative
A steris service technician arrived onsite and found that the stainless steel cover plate on the docking station sustained damage due to the impact of the load and carriage falling.An employee at the user facility stated that the cause of the reported event may have been attributed to improper unloading by the employee subject of the reported event.It is believed that the employee pulled the transfer carriage out too quickly from the docking station or the locking pins were not properly seated.The steris service technician advised user facility personnel of the proper use and operation of the transfer carriage.The transfer carriage and sterilizer are not under steris service contract and are serviced and maintained by the user facility.User facility personnel made the proper repairs and returned the units to service.No additional issues have been reported.
 
Event Description
The user facility reported that an employee was unloading the sterilizer via the transfer carriage when the load fell off the carriage and the carriage fell to the ground.No report of injury.
 
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Brand Name
66" EVOLUTION TRANSFER CARRIAGE
Type of Device
TRANSFER 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
kathryn cadorette
5960 heisley road
mentor, OH 44060
4403927231
MDR Report Key5246884
MDR Text Key32065946
Report Number3005899764-2015-00081
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 11/24/2015
1 Device was Involved in the Event
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
Initial Date Manufacturer Received 10/26/2015
Initial Date FDA Received11/24/2015
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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