MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-02 for CAVITRON JET PLUS PACKAGE G137 manufactured by Dentsply Llc.
[186734965]
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.
Patient Sequence No: 1, Text Type: N, H10
[186734966]
Based on the repair evaluation for the g137 the handpiece cable was damaged, restricting water flow and leaking around the hp cable control. The esd control board is damaged restricting vibration, there was worn out nozzle grip, and pinched tubing's. The handpiece was getting hot , no injury resulted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2424472-2020-00010 |
| MDR Report Key | 9776036 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-02 |
| Date of Report | 2020-02-29 |
| Date Mfgr Received | 2020-01-30 |
| Date Added to Maude | 2020-03-02 |
| 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 JET PLUS PACKAGE |
| Generic Name | SCALER, ULTRASONIC |
| Product Code | ELC |
| Date Received | 2020-03-02 |
| Returned To Mfg | 2020-01-20 |
| Model Number | G137 |
| Catalog Number | G137 |
| 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 | 2020-03-02 |