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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. EAGLE 3000 STAGE 3 STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. EAGLE 3000 STAGE 3 STERILIZER Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Injury (2348); Burn, Thermal (2530)
Event Date 10/24/2016
Event Type  No Answer Provided  
Manufacturer Narrative
A steris service technician arrived at the facility following the event, and was informed that the employee attempted to open the sterilizer door following a morning dart cycle; however, the employee was unable to open the door even by using excess force. The employee returned several hours later and again attempted to open the door. The employee stated that "more force than usual" was used to open the door upon which time steam escaped from the door chamber. The steris service technician inspected the sterilizer and found a broken component on the door lock diaphragm. The technician replaced the door lock diaphragm, door lock thrust washer, and door lock assembly, tested the unit and returned it to service. The sterilizer was installed in august of 1987 and is currently under a steris service contract. The employee injured in this event informed the steris technician that she thought there could be steam pressure inside of the sterilizer chamber due to the amount of force that was used to open the door; however, the employee continued to turn the wheel until the door was opened. The steris technician informed the employee to contact steris for sterilizer inspection or repairs if the door is not operating as expected. The eagle 3000 stage 3 sterilizer operator manual states, "burn and shock hazard: repairs and adjustments should be attempted only by authorized persons fully acquainted with this equipment. Use of inexperienced, unqualified persons to work on the equipment or the installation of unauthorized parts could cause personal injury or result in costly damage!" no further issues have been reported.
 
Event Description
The user facility contacted steris to report an employee was injured when steam escaped the sterilizer chamber upon opening the sterilizer door. The employee resumed working activities following the reported injury. No procedure delays or cancellations were reported.
 
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Brand NameEAGLE 3000 STAGE 3 STERILIZER
Type of DeviceSTERILIZER
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 Key6113033
MDR Text Key60795827
Report Number3005899764-2016-00083
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 11/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2016
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 Received10/24/2016
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

Patient Treatment Data
Date Received: 11/18/2016 Patient Sequence Number: 1
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