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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 80798
Device Problem Overheating of Device (1437)
Patient Problems Burn(s) (1757); Scarring (2061)
Event Date 06/11/2014
Event Type  malfunction  
Event Description
In this event it was reported that a cavitron 30k fsi-pwr-100 insert tip overheated and burned a patient while they were under anesthesia.The patient, who is a physician, did not seek medical attention at the time of the event.However, the patient has informed the dentist that they will require plastic surgery to correct a scar that resulted from the burn.
 
Manufacturer Narrative
Therefore, because surgical intervention is required to preclude permanent damage, this event is reportable per 21 cfr 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.
 
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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
susquehanna commerce ctr w.
221 w. philadelphia st, ste 60
york, PA 17401
7178457511
MDR Report Key4305203
MDR Text Key15818285
Report Number2424472-2014-00007
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 10/28/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number80798
Device Lot Number0501
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/25/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/28/2014
Initial Date FDA Received11/25/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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