MAUDE MDR 5098821

MDR report key
5098821
Report number
9680353-2015-00062
Event key
0
Event type
3
Date of event
2015-09-01
Date received
2015-09-23
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 SYSTEMENDOSCOPE PROCESSORSTERIS CANADA CORPORATIONNZAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-09-230

Event Narratives#

N

Patient 1

THE FACILITY REPORTED THE CHEMICAL DELIVERY SYSTEM (CDS) DISPENSE CANISTERS WERE DISINTEGRATING/ ERODING. THE FACILITY STATED THE EROSION OF THE CANISTERS PRODUCED A CHALK-LIKE SUBSTANCE WHICH WAS UNABLE TO PASS THROUGH ALL OF THE WATER/AIR CHANNELS IN SOME OF THE SCOPES PROCESSED IN THE EPS UNIT. DUE TO THE PRESENCE OF THE CHALK-LIKE SUBSTANCE IN THE SCOPES, THE FACILITY REPROCESSED ALL SCOPES AND VERIFIED THAT THE UNITS WERE FREE FROM CHEMICALS PRIOR TO USE IN PATIENT PROCEDURES. A SERVICE TECHNICIAN ARRIVED AT THE USER FACILITY, INSPECTED THE RELIANCE EPS UNIT AND CONFIRMED THE CUSTOMER WAS USING THE CORRECT, COMPATIBLE STERIS HLD/DG DETERGENT WITH THE RELIANCE EPS. THE TECHNICIAN REVIEWED CYCLE PRINTOUTS FROM THE DAY AND STATED NO ALARMS OR ABORTS HAD OCCURRED. THE RELIANCE EPS OPERATOR MANUAL STATES, "4.3 POST-PROCESSING CHECKLIST: RELIANCE DRY CHEMISTRY CONTAINER AND RELIANCE CDS CHEMICAL DELIVERY SYSTEM VERIFIED FOR ABSENCE OF SOLID RESIDUE." THE TECHNICIAN REPLACED THE DISPENSE CANISTERS, TESTED THE UNIT FOR CORRECT OPERATION AND RETURNED THE UNIT TO SERVICE. THE DISPENSE CANISTERS WERE REQUESTED FOR FURTHER EVALUATION; HOWEVER AT THIS TIME THE CUSTOMER HAS STATED THAT THE CANISTERS ARE NOT AVAILABLE. FOLLOWING THE EVENT, THE FACILITY STATED THEIR SERVICE PROVIDER INDICATED THEY WERE AWARE OF THE ERODING ISSUE WITHIN THE RELIANCE EPS UNIT, HOWEVER DID NOT REPLACE THE CANISTERS WHEN THE ISSUE WAS OBSERVED. THE FACILITY'S SERVICE PROVIDERS HAVE SINCE BEEN INSTRUCTED TO REPLACE THE DISPENSE CANISTERS IMMEDIATELY SHOULD DISINTEGRATION/ERODING BE OBSERVED. NO FURTHER ISSUES HAVE BEEN REPORTED.

D

Patient 1

THE USER FACILITY REPORTED AN ISSUE WITH THE CHEMICAL DELIVERY SYSTEM LOCATED WITHIN THE RELIANCE EPS UNIT. NO INJURY OR PROCEDURAL DELAY OR CANCELLATION WAS REPORTED.