CAVITRON JET SPS ULTRASONIC SCALER AND AIR POLISH SYSTEM G120

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-14 for CAVITRON JET SPS ULTRASONIC SCALER AND AIR POLISH SYSTEM G120 manufactured by Dentsply Llc.

Event Text Entries

[186735340] There has been a previous report received where lack of water flow has caused an overheating insert. Since an overheating insert could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur. As such, this event meets the criteria for reportability per 21 cfr part 803. Multiple unsuccessful attempts were made to obtain the device for evaluation.
Patient Sequence No: 1, Text Type: N, H10


[186735341] While using a g120, they were not able to regulate the water flow and the insert was getting warm; no injury resulted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2424472-2020-00020
MDR Report Key9833146
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-14
Date of Report2020-03-14
Date Mfgr Received2020-02-13
Date Added to Maude2020-03-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. KARL NITTINGER
Manufacturer Street221 W. PHILADELPHIA ST. SUITE 60W
Manufacturer CityYORK, PA
Manufacturer CountryUS
Manufacturer Phone8494229
Manufacturer G1DENTSPLY LLC
Manufacturer Street1301 SMILE WAY
Manufacturer CityYORK, PA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCAVITRON JET SPS ULTRASONIC SCALER AND AIR POLISH SYSTEM
Generic NameSCALER, ULTRASONIC
Product CodeELC
Date Received2020-03-14
Model NumberG120
Catalog NumberG120
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY LLC
Manufacturer Address1301 SMILE WAY YORK, PA US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-14

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