RELIANCE ENDOSCOPE PROCESSOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-15 for RELIANCE ENDOSCOPE PROCESSOR manufactured by Steris Canada Corporation.

Event Text Entries

[102728813] A steris service technician arrived onsite to inspect the unit and found that the hose clamp on the unit's dual pre-filter hose had broken off subsequently causing water to leak onto the floor. The technician replaced the clamp, ran a test cycle, and found the reliance eps to be operating properly. The unit was manufactured in 2011 and no additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10


[102728814] The user facility reported that their reliance eps was leaking water onto the floor. No report of injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9680353-2018-00025
MDR Report Key7342430
Date Received2018-03-15
Date of Report2018-03-15
Date of Event2018-02-16
Date Mfgr Received2018-02-16
Date Added to Maude2018-03-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. DANIEL DAVY
Manufacturer Street5960 HEISLEY ROAD
Manufacturer CityMENTOR OH 44060
Manufacturer CountryUS
Manufacturer Postal44060
Manufacturer Phone4403927453
Manufacturer G1STERIS CANADA CORPORATION
Manufacturer Street490, ARMAND-PARIS
Manufacturer CityQUEBEC, QUEBEC GIC 8A3
Manufacturer CountryCA
Manufacturer Postal CodeGIC 8A3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameRELIANCE ENDOSCOPE PROCESSOR
Generic NamePROCESSOR
Product CodeNZA
Date Received2018-03-15
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTERIS CANADA CORPORATION
Manufacturer Address490 ARMAND-PARIS QUEBEC, QUEBEC GIC 8A3 CA GIC 8A3


Patients

Patient NumberTreatmentOutcomeDate
10 2018-03-15

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