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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON 300 SERIES ULTRASONIC SCALING SYSTEM UNIT; SCALER, ULTRASONIC
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DENTSPLY LLC CAVITRON 300 SERIES ULTRASONIC SCALING SYSTEM UNIT; SCALER, ULTRASONIC Back to Search Results
Model Number G310
Device Problem Overheating of Device (1437)
Patient Problems Burn(s) (1757); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
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.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
 
Event Description
While using a g310 scaler, the inserts and handpieces were getting very hot (new inserts).Hot inserts were burning patients (exact number unknown).No intervention was required.
 
Manufacturer Narrative
We were unable to replicate complaint of inserts overheating.No fault found.
 
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Brand Name
CAVITRON 300 SERIES ULTRASONIC SCALING SYSTEM UNIT
Type of Device
SCALER, ULTRASONIC
Manufacturer (Section D)
DENTSPLY LLC
1301 smile way
york PA 17404
MDR Report Key8800241
MDR Text Key151441008
Report Number2424472-2019-00109
Device Sequence Number1
Product Code ELC
Combination Product (y/n)N
PMA/PMN Number
K150535
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 08/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberG310
Device Catalogue Number8270310
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 06/13/2019
Initial Date FDA Received07/17/2019
Supplement Dates Manufacturer Received06/13/2019
Supplement Dates FDA Received08/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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