CAVIWAVE PRO ULTRASONIC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-12 for CAVIWAVE PRO ULTRASONIC manufactured by Steris Corporation - Distribution Center.

Event Text Entries

[45227394] The facility stated that water was backing up within the lubricant bottle. No water was reported outside of the bottle. A steris service technician arrived on site, inspected the unit and identified that water pressure was above the specification for the unit causing the reported event. The technician informed the customer that incoming water exceeded steris water pressure specification for the caviwave pro ultrasonic unit. The unit was removed from service until a pressure regulator can be installed by the user facility's maintenance department. The unit is not under steris contract for maintenance services and all service is performed by the user facility. No additional issues have been reported with the unit.
Patient Sequence No: 1, Text Type: N, H10


[45227395] The user facility reported water was backing up in their caviwave pro ultrasonic. No injury, procedural delay, or cancellation was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003950207-2016-00005
MDR Report Key5651081
Date Received2016-05-12
Date of Report2016-05-12
Date of Event2016-04-11
Date Mfgr Received2016-04-12
Date Added to Maude2016-05-12
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 ContactMS. KATHRYN CADORETTE
Manufacturer Street5960 HEISLEY ROAD
Manufacturer CityMENTOR OH 44060
Manufacturer CountryUS
Manufacturer Postal44060
Manufacturer Phone4403927231
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCAVIWAVE PRO ULTRASONIC
Generic NameULTRASONIC CLEANER
Product CodeFLG
Date Received2016-05-12
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 2016-05-12

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