MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-07 for BUCHANAN PLUGGER, FINE .06 824-502 manufactured by Kerr (sybron Endo).
[79638966]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1926480-2017-00002 |
| MDR Report Key | 6695781 |
| Date Received | 2017-07-07 |
| Date of Report | 2017-07-07 |
| Date of Event | 2017-06-13 |
| Date Facility Aware | 2017-06-13 |
| Report Date | 2017-06-29 |
| Date Reported to Mfgr | 2017-06-29 |
| Date Added to Maude | 2017-07-07 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTAL ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BUCHANAN PLUGGER, FINE .06 |
| Generic Name | BUCHANAN PLUGGER, FINE .06 |
| Product Code | EKR |
| Date Received | 2017-07-07 |
| Catalog Number | 824-502 |
| Operator | DENTIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KERR (SYBRON ENDO) |
| Manufacturer Address | 1889 W. MISSION BLVD POMONA CA 91766 US 91766 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-07 |