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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL FSI SLI SLIMLINE ULTRASONIC INSERT TIP; ULTRASONIC SCALER
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DENTSPLY PROFESSIONAL FSI SLI SLIMLINE ULTRASONIC INSERT TIP; ULTRASONIC SCALER Back to Search Results
Catalog Number 82005
Device Problem Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
In this event, it was reported that a cavitron 30k fsi-sli-fg-10s insert tip overheated; no injury resulted.
 
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 was evaluated and the temperature was found to be within spec.
 
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Brand Name
FSI SLI SLIMLINE ULTRASONIC INSERT TIP
Type of Device
ULTRASONIC SCALER
Manufacturer (Section D)
DENTSPLY PROFESSIONAL
york PA
Manufacturer Contact
helen lewis
221 w. philadelphia st., ste 60
susquehanna commerce center w.
york, PA 17401
7178457511
MDR Report Key4359542
MDR Text Key18263579
Report Number2424472-2014-00019
Device Sequence Number1
Product Code ELC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K033705
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 11/14/2014
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 Number82005
Device Lot NumberGI
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/20/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/14/2014
Initial Date FDA Received12/12/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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