25K THRU FLOW ULTRASONIC INSERT (TFI) - 10 (STRAIGHT) 6121708

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-04 for 25K THRU FLOW ULTRASONIC INSERT (TFI) - 10 (STRAIGHT) 6121708 manufactured by Dentsply Llc.

Event Text Entries

[186735626] While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per 21cfr 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: 07/31/2020 the temperature is 96. 01? Degrees meets spec. Specification states not to exceed 118. 4? F. (per frs-9175 rev. 9).
Patient Sequence No: 1, Text Type: N, H10


[186735627] While using a 25k tfi-10 insert, the insert was overheating when in operation. The event outcome is unknown as of this mdr evaluation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2424472-2020-00011
MDR Report Key9788609
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-03-04
Date of Report2020-03-04
Date Mfgr Received2020-02-03
Date Added to Maude2020-03-04
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 Name25K THRU FLOW ULTRASONIC INSERT (TFI) - 10 (STRAIGHT)
Generic NameSCALER, ULTRASONIC
Product CodeELC
Date Received2020-03-04
Returned To Mfg2020-02-12
Model NumberNA
Catalog Number6121708
Lot NumberNA
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 2020-03-04

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