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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL CAVITRON BOBCAT PRO; ULTRASONIC SCALER
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DENTSPLY PROFESSIONAL CAVITRON BOBCAT PRO; ULTRASONIC SCALER Back to Search Results
Catalog Number G130
Device Problem Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/13/2014
Event Type  malfunction  
Event Description
In this event it was reported that while a customer was using a cavitron g130 scaler, the insert was "heating up." no injury resulted.
 
Manufacturer Narrative
While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.This event, therefore, 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
CAVITRON BOBCAT PRO
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 Key4359543
MDR Text Key15320219
Report Number2424472-2014-00027
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 11/13/2014
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 NumberG130
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/26/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/13/2014
Initial Date FDA Received12/12/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/01/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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