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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. 48" CENTURY STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 48" CENTURY STERILIZER Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Pain (1994); Sprain (2083)
Event Date 05/09/2018
Event Type  Malfunction  
Manufacturer Narrative

A steris service technician arrived onsite following the event to inspect the 48" century sterilizer. The technician tested the functionality of the door and door seal and was unable to duplicate the reported event. The technician replaced the unit's door seal and air solenoid valve as a precautionary measure while onsite. A review of the device history record for the subject sterilizer was reviewed and confirmed that the unit was manufactured in accordance with specification. The technician tested the unit following the repairs and confirmed that the sterilizer was operating according to specification and returned the unit to service. No additional issues with the door unlock function have been reported.

 
Event Description

The user facility reported that during the use of a 48" century sterilizer, the door would not unlock at the end of a successfully completed cycle. At the end of the cycle, the customer tried to force the door lever to the unlock position and felt pain in their shoulder. The employee sought medical treatment for the reported shoulder pain and was diagnosed with a sprain.

 
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Brand Name48" CENTURY 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 Key7579188
MDR Text Key110723955
Report Number3005899764-2018-00040
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 06/07/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/07/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received05/10/2018
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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