FDA.reportPublic FDA data

MAUDE MDR 6089893

MDR report key
6089893
Report number
9680353-2016-00111
Event key
0
Event type
3
Date of event
2016-10-10
Date received
2016-11-09
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
MS. KATHRYN CADORETTE
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 EPS ENDOSCOPE PROCESSING SYSTEMPROCESSING SYSTEMSTERIS CANADA CORPORATIONNZAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-11-0901. O

Event Narratives#

N

Patient 1

A STERIS SERVICE TECHNICIAN ARRIVED ON-SITE, INSPECTED THE UNIT, AND IDENTIFIED THE CRIMP HOLDING THE HOSE TO THE HOT WATER SUPPLY VALVE FAILED CAUSING THE HOSE TO BECOME DETACHED. THE TECHNICIAN REPLACED THE CRIMP, TESTED THE UNIT, AND CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION. UPON FURTHER INVESTIGATION, THE TECHNICIAN IDENTIFIED THE USER FACILITY'S WATER PRESSURE WAS OUT OF SPECIFICATION, CAUSING THE CRIMP ON THE WATER SUPPLY VALVE TO FAIL. NO ADDITIONAL ISSUES HAVE BEEN IDENTIFIED.

D

Patient 1

THE USER FACILITY STATED THAT A HOT WATER SUPPLY HOSE ON THEIR RELIANCE EPS BECAME DETACHED FROM THE WALL CAUSING A WATER LEAK. PROCEDURE DELAYS OCCURRED AS A RESULT OF THE REPORTED EVENT.