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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. CENTURY STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. CENTURY 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 08/26/2021
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite to inspect the unit and found that the magnet that holds the door in place was no longer making an adequate connection.The unit was installed in 2008 making it approximately 13 years old at the time of the reported event.The technician replaced the magnet, tested the unit, confirmed it to be operating according to specification, and returned it to service.No additional issues have been reported.
 
Event Description
The user facility reported that while an employee was unloading their century sterilizer, the lower panel fell and contacted the employee's foot.Medical treatment was administered (ice).
 
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Brand Name
CENTURY 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
MDR Report Key12522645
MDR Text Key280542492
Report Number3005899764-2021-00051
Device Sequence Number1
Product Code FLE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial
Report Date 09/23/2021
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
Initial Date Manufacturer Received 08/26/2021
Initial Date FDA Received09/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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