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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE ENDOSCOPE PROCESSING SYSTEM; RELIANCE EPS
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STERIS CANADA CORPORATION RELIANCE ENDOSCOPE PROCESSING SYSTEM; RELIANCE EPS Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/08/2017
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived on-site to inspect the reliance endoscope processing system and found that the chemical pump in the processing system had shorted due to a blown fuse.The technician repaired the processor, ran a test cycle, and found the unit to be operational.No additional issues have been reported.
 
Event Description
The user facility reported their reliance endoscope processing system was not operating properly.No report of injury, procedure delays or cancellations.
 
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Brand Name
RELIANCE ENDOSCOPE PROCESSING SYSTEM
Type of Device
RELIANCE EPS
Manufacturer (Section D)
STERIS CANADA CORPORATION
490 armand-paris
quebec, quebec GIC 8 A3
CA  GIC 8A3
Manufacturer (Section G)
STERIS CANADA CORPORATION
490, armand-paris
quebec, quebec GIC 8 A3
CA   GIC 8A3
Manufacturer Contact
kathryn cadorette
5960 heisley road
mentor, OH 44060
4403927231
MDR Report Key6309119
MDR Text Key67208556
Report Number9680353-2017-00013
Device Sequence Number1
Product Code NZA
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
Type of Report Initial
Report Date 02/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/08/2017
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
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