MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-12 for CAVITRON PLUS ULTRASONIC SCALER WITH TAP-ON TECHNOLOGY G136 8184001 manufactured by Dentsply Llc.
[186734824]
There has been a previous report received where lack of water flow has caused an overheating insert. Since an overheating insert could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur. As such, this event meets the criteria for reportability per 21 cfr part 803. This report was originally submitted under mfr report # 2424472-2019-00214 by mistake. When we submitted the actual report for 2424472-2019-00214 and received a duplicate number error, this discrepancy was discovered. This submission is to re-submit this report under the correct mfr report # 2424472-2018-00214.
Patient Sequence No: 1, Text Type: N, H10
[186734825]
Based on the device evaluation of a cavitron plus on december 6, 2018, the water system clogged up with debris and the sterimate was burned; no injury resulted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2424472-2018-00214 |
| MDR Report Key | 9703463 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date Mfgr Received | 2018-12-06 |
| Date Added to Maude | 2020-02-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KARL NITTINGER |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 8494229 |
| Manufacturer G1 | DENTSPLY LLC |
| Manufacturer Street | 1301 SMILE WAY |
| Manufacturer City | YORK, PA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAVITRON PLUS ULTRASONIC SCALER WITH TAP-ON TECHNOLOGY |
| Generic Name | SCALER, ULTRASONIC |
| Product Code | ELC |
| Date Received | 2020-02-12 |
| Returned To Mfg | 2018-12-03 |
| Model Number | G136 |
| Catalog Number | 8184001 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY LLC |
| Manufacturer Address | 1301 SMILE WAY YORK, PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-12 |