RELIANCE EPS ENDOSCOPE PROCESSING SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-16 for RELIANCE EPS ENDOSCOPE PROCESSING SYSTEM manufactured by Steris Canada Corporation.

Event Text Entries

[55221124] A steris service technician arrived onsite to inspect the processor and found user facility personnel had reconnected the hose subject of the reported event. The steris technician confirmed that the hot water supply hose was properly connected with a hose clamp, ran a test cycle and confirmed the unit to be operating properly.
Patient Sequence No: 1, Text Type: N, H10


[55221125] The user facility reported a hose disconnected from their reliance eps subsequently causing water to leak out. No report of injury or procedural delays or cancellations.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9680353-2016-00095
MDR Report Key5957071
Date Received2016-09-16
Date of Report2016-09-16
Date of Event2016-08-18
Date Mfgr Received2016-08-18
Date Added to Maude2016-09-16
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 ContactMS. KATHRYN CADORETTE
Manufacturer Street5960 HEISLEY ROAD
Manufacturer CityMENTOR OH 44060
Manufacturer CountryUS
Manufacturer Postal44060
Manufacturer Phone4403927231
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 EPS ENDOSCOPE PROCESSING SYSTEM
Generic NamePROCESSING SYSTEM
Product CodeNZA
Date Received2016-09-16
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
101. Other 2016-09-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.