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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" CENTURY STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 60" CENTURY STERILIZER Back to Search Results
Device Problem Device Slipped (1584)
Patient Problem Injury (2348)
Event Date 08/19/2019
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived on site to inspect the 60" century sterilizer and found the bearing within the door lock assembly required lubrication. As the bearing required lubrication, the lever that locks the door was difficult to move resulting in the reported event. The technician lubricated the bearing, tested the unit, confirmed it to be operating according to specification, and returned it to service. A 3-year complaint review indicates this to be an isolated event. No additional issues have been reported.
 
Event Description
The user facility reported that an employee obtained a shoulder injury while attempting to lock the door to their 60" century sterilizer. The user facility did not disclose if medical treatment was sought or administered.
 
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Brand Name60" CENTURY 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 Key8995063
MDR Text Key193750965
Report Number3005899764-2019-00078
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 09/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/11/2019
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 Received08/19/2019
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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