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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON BUILT-IN ULTRASONIC SCALER; SCALER, ULTRASONIC
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DENTSPLY LLC CAVITRON BUILT-IN ULTRASONIC SCALER; SCALER, ULTRASONIC Back to Search Results
Model Number G139
Device Problem Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
While no serious injury resulted in this event, there has been a previous report received where an overheating insert 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 results are not available as of this report.Evaluation results will be submitted as they become available.
 
Event Description
While using a g139 scaler, the inserts and module are getting hot; no injury resulted.
 
Manufacturer Narrative
Unit was received by itself, no accessories for evaluation.No unit activation due to a shorted power supply pcb.Dead unit.
 
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Brand Name
CAVITRON BUILT-IN ULTRASONIC SCALER
Type of Device
SCALER, ULTRASONIC
Manufacturer (Section D)
DENTSPLY LLC
1301 smile way
york PA 17404
MDR Report Key8196678
MDR Text Key131595899
Report Number2424472-2018-00203
Device Sequence Number1
Product Code ELC
Combination Product (y/n)N
PMA/PMN Number
K052334
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberG139
Device Catalogue Number8800701
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2018
Initial Date Manufacturer Received 11/27/2018
Initial Date FDA Received12/26/2018
Supplement Dates Manufacturer Received01/25/2019
Supplement Dates FDA Received02/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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