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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 STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 66" EVOLUTION STERILIZER Back to Search Results
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/18/2021
Event Type  malfunction  
Event Description
The user facility reported that the top panel on their evolution sterilizer fell off of the unit. No report of injury.
 
Manufacturer Narrative
The unit had been serviced a couple days prior to the reported event by steris for an unrelated service request. A steris service technician arrived onsite to inspect the unit and was informed by the customer that they reattached the panel to the unit prior to his arrival. The technician inspected the unit and found the panel to be properly attached. No repairs were needed, and the unit was returned to service. No additional issues have been reported.
 
Manufacturer Narrative
The unit had been serviced a couple days prior to the reported event by steris for an unrelated service request. A steris service technician arrived onsite to inspect the unit and was informed by the customer that they reattached the panel to the unit prior to his arrival. The technician inspected the unit and found the panel to be properly attached. No repairs were needed, and the unit was returned to service. No additional issues have been reported.
 
Event Description
The user facility reported that the top panel on their evolution sterilizer fell off of the unit. No report of injury.
 
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Brand Name66" EVOLUTION STERILIZER
Type of DeviceSTERILIZER
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 Key13020414
MDR Text Key285351112
Report Number3005899764-2021-00062
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,Followup
Report Date 12/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/16/2021
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
Date Manufacturer Received11/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/22/2016
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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