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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. 20" EAGLE STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 20" EAGLE STERILIZER Back to Search Results
Device Problems Increase in Pressure (1491); Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)
Patient Problem Burn, Thermal (2530)
Event Date 05/21/2018
Event Type  malfunction  
Manufacturer Narrative
The instruments subject of the reported event were reprocessed prior to use as the cycle did not complete successfully. A steris technician arrived onsite to inspect the 20" eagle sterilizer following the reported event. The technician spoke with the user facility and confirmed the unit did not evacuate all water and steam condensate from the chamber resulting in excess pressure chamber. This pressure prevented the sterilizer door from opening following the cycle. The employee shut the unit off for approximately 30 minutes and restarted it in an attempt to lower the pressure chamber. The employee then cracked the door open to slowly release the remaining pressure, which caused the remaining water to pour out of the sterilizer and onto the employee's thighs. The sterilizer was installed at the user facility's account on (b)(4) 1996 and is not under a steris service contract agreement for maintenance activities. While onsite, the technician inspected the sterilizer and found the root cause of the event to be failure of the ck1 check valve. The technician identified that a component of the check valve detached and became lodged in the unit's ejector, preventing all water from being removed from the chamber during the vacuum pull phase. The technician completed the necessary repairs, tested the unit, and found the sterilizer to be operating according to specifications. The operator manual (1-1) states, "steam may be released from the chamber when door is opened. Step back from the sterilizer each time the door is opened to minimize contact with the steam vapor. " no additional issues have been reported.
 
Event Description
The user facility reported an employee experienced a burn on their thighs while operating a 20" eagle sterilizer. The employee sought and received medical treatment and returned to work the next day. No procedure delay or cancellation was reported.
 
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Brand Name20" EAGLE 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
daniel davy
5960 heisley road
mentor, OH 44060
4403927453
MDR Report Key7622715
MDR Text Key112050379
Report Number3005899764-2018-00044
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 06/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/21/2018
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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