30K FOCUSED SPRAY POWERLINE ULTRASONIC INSERT - 100 80798

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 2020-03-11 for 30K FOCUSED SPRAY POWERLINE ULTRASONIC INSERT - 100 80798 manufactured by Dentsply Llc.

Event Text Entries

[186735220] 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. Visually inspected and verified the insert has water and vibration meets spec. The insert was tested on a digital thermometer gauge # 6116 due date: 07/31/19 the temperature is 91. 06? Degrees meets spec. Specification states not to exceed 118. 4? F. (per frs-9175 rev. 9). Insert has a leak at the hp sealing o-ring area does not meet spec.
Patient Sequence No: 1, Text Type: N, H10


[186735221] While using a 30k fsi-pwr-100 insert, there was no water flow and the insert was running hot; no injury resulted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2424472-2020-00017
MDR Report Key9821934
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-11
Date of Report2020-03-11
Date Mfgr Received2020-02-10
Date Added to Maude2020-03-11
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 Name30K FOCUSED SPRAY POWERLINE ULTRASONIC INSERT - 100
Generic NameSCALER, ULTRASONIC
Product CodeELC
Date Received2020-03-11
Returned To Mfg2020-02-28
Model NumberNA
Catalog Number80798
Lot Number19325,00038670
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY LLC
Manufacturer Address1301 SMILE WAY YORK, PA US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-11

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