• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL 30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 10S STRAIGHT; SCALER, ULTRASONIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DENTSPLY PROFESSIONAL 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 has not been returned as of this report.Evaluation results will be submitted as they become available.
 
Event Description
While using a 30k fsi-sli-10s insert, the insert was popping out of handpiece so the rep changed the o-ring, but now it gets hot; no injury resulted.
 
Manufacturer Narrative
Evaluation found low water flow because the insert is clogged.The insert does get hot.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 10S STRAIGHT
Type of Device
SCALER, ULTRASONIC
Manufacturer (Section D)
DENTSPLY PROFESSIONAL
1301 smile way
york PA 17404
Manufacturer (Section G)
DENTSPLY PROFESSIONAL
1301 smile way
york PA 17404
Manufacturer Contact
helen lewis
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494229
MDR Report Key7151154
MDR Text Key96028892
Report Number2424472-2017-00229
Device Sequence Number1
Product Code ELC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052334
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date 02/16/2018
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 Number17261
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/28/2017
Initial Date FDA Received12/28/2017
Supplement Dates Manufacturer Received01/17/2018
Supplement Dates FDA Received02/16/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-