CAVIWAVE CONSOLE CLEANER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-14 for CAVIWAVE CONSOLE CLEANER manufactured by Steris Corporation - Distribution Center.

Event Text Entries

[111851973] There were no instruments present during the time of the reported event. A steris service technician arrived onsite to inspect the caviwave unit and found that the y-strainer cracked on the incoming water line subsequently causing the reported event to occur. The technician replaced the y-strainer and associated components, tested the caviwave console cleaner, and found it be operational. The unit was installed at the customer's location in 2011 and is under steris service agreement for maintenance. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10


[111851974] The user facility reported event that their caviwave console cleaner was leaking water. No report of injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003950207-2018-00003
MDR Report Key7603574
Date Received2018-06-14
Date of Report2018-06-14
Date of Event2018-05-16
Date Mfgr Received2018-05-16
Date Added to Maude2018-06-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. DANIEL DAVY
Manufacturer Street5960 HEISLEY ROAD
Manufacturer CityMENTOR OH 44060
Manufacturer CountryUS
Manufacturer Postal44060
Manufacturer Phone4403927453
Manufacturer G1STERIS CORPORATION - DISTRIBUTION CENTER
Manufacturer Street6100 HEISLEY RD
Manufacturer CityMENTOR OH 44060
Manufacturer CountryUS
Manufacturer Postal Code44060
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCAVIWAVE CONSOLE CLEANER
Generic NameCAVIWAVE CLEANER
Product CodeFLG
Date Received2018-06-14
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTERIS CORPORATION - DISTRIBUTION CENTER
Manufacturer Address6100 HEISLEY RD MENTOR OH 44060 US 44060


Patients

Patient NumberTreatmentOutcomeDate
10 2018-06-14

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