• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. EAGLE STERILIZER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STERIS MEXICO, S. DE R.L. DE C.V. EAGLE STERILIZER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn, Thermal (2530)
Event Date 05/02/2019
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the eagle sterilizer.Upon his inspection, the technician found that the user facility's water pressure was set too high.The technician informed the facility and the facility made the appropriate repairs.The technician found that the unit was unable to pass a dart test and had multiple steam leaks.The technician made the necessary repairs including replacing the door gasket, steam chamber valve and fc5 flow control, ran a test cycle, and found the unit to be operating according to specification.The sterilizer was returned to service.While onsite, the technician was informed that the employee subject of the event was wearing proper ppe when the event occurred.However, based on the description of the event and severity of the burn it is unlikely the employee was wearing proper ppe.The eagle sterilizer operator manual (pg 4-7) states: "warning: do not service sterilizer steam traps or strainer until the sterilizer has reached room temperature.Piping may contain hot water, so protective clothing and hand protection must be worn".The eagle sterilizer was installed in 2007 and is not under steris service agreement for maintenance activities.The facilities biomed department is responsible for all maintenance activities.A steris account manager will offer in-service training on the proper use and maintenance of the eagle sterilizer.No additional issues have been reported.
 
Event Description
The user facility reported their employee obtained a burn while performing maintenance on their eagle sterilizer.Medical treatment was sought and administered.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EAGLE STERILIZER
Type of Device
STERILIZER
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 Key8658293
MDR Text Key146933023
Report Number3005899764-2019-00056
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 05/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/02/2019
Initial Date FDA Received05/31/2019
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
Patient Sequence Number1
-
-