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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. AMSCO C STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. AMSCO C STERILIZER Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/15/2016
Event Type  No Answer Provided  
Manufacturer Narrative
The unit is not serviced or maintained by steris.   a steris service technician and account manager are conducting an investigation in conjunction with the user facility's maintenance personnel.   a follow up report will be submitted once additional information becomes available.
 
Event Description
The user facility reported their amsco c sterilizer was not operating properly. No injury, procedure delay, or cancellation was reported.
 
Manufacturer Narrative
The user facility reported their amsco sterilizer overheated emitting a burning odor. A steris account manager was dispatched to the user facility to obtain additional information regarding the reported event. The account manager identified that the user facility removed the amsco sterilizer from service. The user facility services and maintains the sterilizer and declined to disclose additional details regarding the reported event; the user facility did not release the unit for further evaluation by steris. The amsco sterilizer was replaced. No additional issues have been reported by the user facility.
 
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Brand NameAMSCO C 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 Key6178846
MDR Text Key62698016
Report Number3005899764-2016-00088
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,Followup
Report Date 12/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2016
Was Device Evaluated by Manufacturer? No Answer Provided
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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