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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY LLC 30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 10S STRAIGHT; SCALER, ULTRASONIC
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DENTSPLY LLC 30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 10S STRAIGHT; SCALER, ULTRASONIC Back to Search Results
Catalog Number 80395
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 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 results are not available as of this report.Evaluation results will be submitted as they become available.
 
Event Description
While the customer was using a 30k fsi-sli-10s insert, it gets very hot during use; no injury resulted.
 
Manufacturer Narrative
The device was evaluated and found to be within specification.
 
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Brand Name
30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 10S STRAIGHT
Type of Device
SCALER, ULTRASONIC
Manufacturer (Section D)
DENTSPLY LLC
1301 smile way
york PA 17404
MDR Report Key9532880
MDR Text Key186725448
Report Number2424472-2019-00203
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 foreign,health professional
Type of Report Initial,Followup
Report Date 02/28/2020
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 Catalogue Number80395
Device Lot Number18340
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2019
Initial Date Manufacturer Received 11/14/2019
Initial Date FDA Received12/30/2019
Supplement Dates Manufacturer Received11/14/2019
Supplement Dates FDA Received02/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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