FDA.reportPublic FDA data

MAUDE MDR 5398589

MDR report key
5398589
Report number
3003950207-2016-00001
Event key
0
Event type
3
Date of event
2015-12-31
Date received
2016-01-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
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
1CAVIWAVE PRO ULTRASONIC CONSOLEULTRASONIC CONSOLESTERIS CORPORATION - DISTRIBUTION CENTERFLGY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-01-290

Event Narratives#

N

Patient 1

A STERIS FIELD SERVICE TECHNICIAN ARRIVED ONSITE, INSPECTED THE UNIT, AND IDENTIFIED THE USER FACILITY'S WATER PRESSURE WAS ABOVE THE RECOMMENDED SPECIFICATIONS FOR OPERATION. THE TECHNICIAN RECORDED THE FACILITY'S WATER PRESSURES OVER 100 PSI. THE FORCE OF THE WATER PRESSURE ALLOWED FOR AN O-RING ON THE FILTER HOUSING TO FAIL CAUSING THE REPORTED WATER LEAK. SECTION 2 OF THE OPERATOR MANUAL FOR THE CAVIWAVE PRO ULTRASONIC CLEANER STATES, "OTHER FACILITY REQUIREMENTS: [HOT, COLD, AND DEIONIZED WATER]: 38 PSI MAXIMUM." IT WAS CONFIRMED THAT UPON INSTALLATION, THE WATER PRESSURE SPECIFICATIONS WERE WITHIN THE RECOMMENDED RANGE FOR OPERATION. THE TECHNICIAN REPLACED THE FILTERS AND O-RING, TESTED THE UNIT, AND CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION. THE TECHNICIAN ADVISED THE USER FACILITY TO INSTALL A PRESSURE REGULATOR TO ACCOUNT FOR FLUCTUATIONS IN WATER PRESSURE. SINCE THE REPORTED EVENT, THE USER FACILITY HAS INSTALLED A PRESSURE REGULATOR AS RECOMMENDED BY THE STERIS FIELD SERVICE TECHNICIAN.

D

Patient 1

THE USER FACILITY REPORTED THEIR CAVIWAVE PRO ULTRASONIC CLEANER WAS LEAKING WATER. NO REPORT OF INJURY.