MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-11-20 for LIGHT FANTASTIC HBC LFCII manufactured by Kavo Dental Technologies, Llc.
[127878269]
Upon evaluation by the distributor service technician it was determined the roll pins were not installed by the distributor during installation. The roll pins will prevent the light from unscrewing from the ceiling mounted tripod assembly after installation. The pelton & crane installation instructions clearly states to properly install the roll pins during installation of the ceiling mounted dental light. The installation instructions also lists warnings to ensure the roll pins are installed. The pelton & crane ceiling mounted dental light is over 24 years old and past the life of the device.
Patient Sequence No: 1, Text Type: N, H10
[127878270]
It was reported to kavo dental technologies, llc that a pelton & crane lfcii dental light fell dowm from the ceiling and was defected away by the dr. During routine patient dental treatment causing a small bruise to the doctor's arm. There were no serious injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2018-00031 |
| MDR Report Key | 8088738 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-11-20 |
| Date of Report | 2018-11-20 |
| Date of Event | 2018-10-18 |
| Date Mfgr Received | 2018-10-22 |
| Device Manufacturer Date | 1994-04-01 |
| Date Added to Maude | 2018-11-20 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. FRANK RAY |
| Manufacturer Street | 11727 FRUEHAUF DRIVE |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal | 28273 |
| Manufacturer Phone | 7045877227 |
| Manufacturer G1 | KAVO DENTAL TECHNOLOGIES, LLC |
| Manufacturer Street | 11727 FRUEHAUF DRIVE |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 28273 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGHT FANTASTIC |
| Generic Name | DENTAL LIGHT |
| Product Code | EAZ |
| Date Received | 2018-11-20 |
| Model Number | HBC |
| Catalog Number | LFCII |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KAVO DENTAL TECHNOLOGIES, LLC |
| Manufacturer Address | 11727 FRUEHAUF DRIVE CHARLOTTE NC 28273 US 28273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-20 |