MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-04 for 25K THRU FLOW ULTRASONIC INSERT (TFI) - 10 (STRAIGHT) 6121708 manufactured by Dentsply Llc.
[186735010]
While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per 21cfr part 803. Visually inspected and verified the insert has water and vibration meets spec. The insert was tested on a digital thermometer gauge # 6116 due date: 07/31/2020 the temperature is 96. 01? Degrees meets spec. Specification states not to exceed 118. 4? F. (per frs-9175 rev. 9).
Patient Sequence No: 1, Text Type: N, H10
[186735011]
While using a 25k tfi-10 insert, the insert was overheating when in operation. The event outcome is unknown as of this mdr evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2424472-2020-00012 |
| MDR Report Key | 9788605 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-03-04 |
| 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 | 25K THRU FLOW ULTRASONIC INSERT (TFI) - 10 (STRAIGHT) |
| Generic Name | SCALER, ULTRASONIC |
| Product Code | ELC |
| Date Received | 2020-03-04 |
| Returned To Mfg | 2020-02-12 |
| Model Number | NA |
| Catalog Number | 6121708 |
| 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 | 2020-03-04 |