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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KERR (SYBRON ENDO) BUCHANAN PLUGGER, FINE .06
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KERR (SYBRON ENDO) BUCHANAN PLUGGER, FINE .06 Back to Search Results
Catalog Number 824-502
Device Problem Sparking (2595)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/13/2017
Event Type  malfunction  
Event Description
On (b)(6) 2017 customer called in stating that buchanan plugger tip, which is used with sybronendo system b heat source sparked and no longer works, and was unable to provide more information.There was no patient injury.(b)(6) 2017 customer responded to call-back attempts and stated that electrical sparks were coming out from the tip while engaged to the patient's tooth.The doctor was using the instrument to melt off excess gutta percha as per root canal procedure when this occurred.The tip was replaced with another one and then the device functioned properly.These plugger tips as well as the system b heat source device are manufactured by kerr (sybron endo).The manufacturer has been contacted.The device has been returned to our facility, and will be returned to the original manufacturer.
 
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Brand Name
BUCHANAN PLUGGER, FINE .06
Type of Device
BUCHANAN PLUGGER, FINE .06
Manufacturer (Section D)
KERR (SYBRON ENDO)
1889 w. mission blvd
pomona CA 91766
MDR Report Key6695781
MDR Text Key79638966
Report Number1926480-2017-00002
Device Sequence Number1
Product Code EKR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Dental Assistant
Type of Report Initial
Report Date 06/29/2017,07/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Dentist
Device Catalogue Number824-502
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/13/2017
Date Report to Manufacturer06/29/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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