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 2017-06-14 for RELIANCE ENDOSCOPE PROCESSOR manufactured by Steris Canada Corporation.

Event Text Entries

[77734981] A steris service technician arrived onsite to inspect the reliance endoscope processor and found that a wire in the unit was resting on a heat connector causing the insulation component to melt off the wire. The technician re-wrapped the wire with electrical tape and rerouted the wire to prevent contact with other components. The technician ran a test cycle and confirmed the unit was operating per specifications. The reliance endoscope processor was manufactured in 2009 and has been in use for 8 years. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10


[77734982] The user facility reported a burning odor emitting from their reliance endoscope processor. No injuries, procedure delays or cancellations resulted from the reported event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9680353-2017-00046
MDR Report Key6641548
Date Received2017-06-14
Date of Report2017-06-14
Date of Event2017-05-23
Date Mfgr Received2017-05-23
Date Added to Maude2017-06-14
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. LYNDSEY SNYDER
Manufacturer Street5960 HEISLEY ROAD
Manufacturer CityMENTOR OH 44060
Manufacturer CountryUS
Manufacturer Postal44060
Manufacturer Phone4403927386
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 NameENDOSCOPE PROCESSOR
Product CodeNZA
Date Received2017-06-14
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 2017-06-14

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