FDA Adverse Event
Malfunction
Summary report: N
30K FSI-SLI-FG-1000 INS,PKD
MDR report key: 24145041
·
Received January 22, 2026
Report
- Report Number
- 2424472-2026-00505
- Event Type
- Malfunction
- Date Received
- January 22, 2026
- Report Date
- April 30, 2026
- Manufacturer
- DENTSPLY LLC
- Product Code
- ELC
- UDI-DI
- D003820081
- PMA / PMN Number
- K052334/K970
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
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.
Description of Event or Problem · 0
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-FG-1000 INS,PKD ALLEGEDLY OVERHEATED AND HAD LACK OF WATER FLOW. NO INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 361214 | 30K FSI-SLI-FG-1000 INS,PKD | SCALER, ULTRASONIC | ELC | DENTSPLY LLC | 00159325 | D003820081 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |