MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-11 for 30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 10S STRAIGHT 80395 manufactured by Dentsply Llc.
[186735146]
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. Visually inspected and confirmed the insert is clogged no water flow does not meet spec. Could not test for temperature insert is clogged. The insert got clogged because of rust. The maintenance and insert handling is unknown in the field. Inserts left standing wet corrode and clog. Inserts are tested 100% in the production floor for water flow and the put in an oven to remove moisture. There is no enough evidence to say that this was an issue cause by the manufacturing process.
Patient Sequence No: 1, Text Type: N, H10
[186735147]
While using a 30k fsi-sli-10s insert, there was no water flow and the insert was getting warm; no injury resulted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2424472-2020-00013 |
| MDR Report Key | 9817721 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-05 |
| Date Added to Maude | 2020-03-11 |
| 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 | 30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 10S STRAIGHT |
| Generic Name | SCALER, ULTRASONIC |
| Product Code | ELC |
| Date Received | 2020-03-11 |
| Returned To Mfg | 2020-02-10 |
| Model Number | NA |
| Catalog Number | 80395 |
| Lot Number | 19276,00036427 |
| 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 | 2020-03-11 |