FDA.reportPublic FDA data

MAUDE MDR 5829414

MDR report key
5829414
Report number
9680353-2016-00073
Event key
0
Event type
3
Date of event
2016-07-01
Date received
2016-07-28
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 ENDOSCOPE PROCESSING SYSTEMPROCESSING SYSTEMSTERIS CANADA CORPORATIONNZAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-07-280

Event Narratives#

N

Patient 1

THE USER FACILITY REPORTED THAT TESTING WAS PERFORMED ON DEVICES PROCESSED IN A EPS UNIT; THE FACILITY CONTACTED STERIS IN ORDER TO OBTAIN INFORMATION REGARDING THE TEST RESULTS. INSTRUMENTS USED DURING THE TESTING WERE NOT UTILIZED IN PATIENT PROCEDURES. NO INJURIES OR PROCEDURAL DELAYS OR CANCELLATIONS WERE REPORTED. THE USER FACILITY'S RELIANCE EPS UNITS ARE UNDER STERIS SERVICE CONTRACT AND HAVE RECEIVED ROUTINE PREVENTIVE MAINTENANCE. NO ISSUES WERE NOTED WITH THE RELIANCE EPS UNITS DURING PREVENTIVE MAINTENANCE AND THE UNITS WERE FOUND TO BE OPERATING ACCORDING TO SPECIFICATIONS. THE RELIANCE EPS UNITS ARE CURRENTLY IN USE AT THE USER FACILITY. A STERIS ACCOUNT MANAGER HAS MADE REPEATED ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE TESTING THAT WAS CONDUCTED AT THE USER FACILITY HOWEVER, USER FACILITY PERSONNEL DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE NATURE AND PURPOSE OF THE REPORTED TESTING, IF THE FACILITY WAS FOLLOWING PROPER OPERATING PROCEDURES FOR THE EPS UNIT DURING THE TESTING, AND IF THE DEVICES WHICH WERE PROCESSED IN THE EPS ARE VALIDATED FOR USE IN THE UNIT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP REPORT WILL BE FILED.

D

Patient 1

THE USER FACILITY CONTACTED STERIS WITH AN INQUIRY REGARDING THEIR RELIANCE EPS UNIT.