FDA.reportPublic FDA data

MAUDE MDR 7310101

MDR report key
7310101
Report number
9680353-2018-00022
Event key
0
Event type
3
Date of event
2018-01-31
Date received
2018-03-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. DANIEL DAVY
Address
5960 HEISLEY ROAD MENTOR OH 44060 US
Phone
440-440-4403
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RELIANCE ENDOSCOPE PROCESSORPROCESSORSTERIS CANADA CORPORATIONNZAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-03-020

Event Narratives#

N

Patient 1

ALL INSTRUMENTS WERE REPROCESSED PRIOR TO USE IN PROCEDURES. DURING THE TIME OF THE REPORTED EVENT, THE UNIT'S FILTRATION SYSTEM WAS NOT OPERATING PROPERLY WHICH CAUSED THE CYCLE TO ABORT. A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE UNIT AND FOUND THAT ONE OF THE UNIT'S ELECTRICAL COMPONENTS HAD SHORTED SUBSEQUENTLY CAUSING A BURNING ODOR AND THE FILTRATION SYSTEM TO NOT OPERATE PROPERLY. ADDITIONALLY, THE TECHNICIAN OBSERVED A SMALL AMOUNT OF HEAT DAMAGE AROUND THE ELECTRICAL COMPONENT. THE TECHNICIAN REPLACED THE FILTRATION SYSTEM WHICH HOUSES THE ELECTRICAL COMPONENT, RAN A TEST CYCLE, AND CONFIRMED THE UNIT TO BE OPERATING ACCORDING TO SPECIFICATION. THE ROOT CAUSE OF THE SHORTED ELECTRICAL COMPONENT COULD NOT BE DETERMINED AS THE DAMAGED COMPONENT WAS DISCARDED. THE UNIT WAS MANUFACTURED IN 2011 AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

D

Patient 1

THE USER FACILITY REPORTED A BURNING ODOR EMITTING FROM THEIR RELIANCE EPS. NO REPORT OF INJURY, PROCEDURE DELAY OR CANCELLATION.