MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-11-25 for HELIOS 3000 WALL MOUNTED LIGHT HL3WL manufactured by Pelton & Crane.
[5211191]
It was reported that a dental professional was moving a pelton and crane helios 3000 dental light away after use when the arm assembly broke causing the light to fall down towards the ground. The light grazed the patient on the side of their head; however, the patient was not injured.
Patient Sequence No: 1, Text Type: D, B5
[12711621]
Upon evaluation of the light arm rear knuckle assembly, it was observed that a portion of the knuckle had broken off the main knuckle assembly. The fracture of the knuckle started where the rotational stop pin is located. The rotational stop pin is designed to prevent the operator from rotating the light more than 360 degrees during use. It was also observed that the rotational stop pin was missing. The round counter bore hole where the stop pin is located was deformed in an oblong shape. This is indicative of force being applied to the rotational stop pin as the direction of the deformation was towards the section of the knuckle casting that had broken off. As a result, the rotational stop pin was exposed to an excessive force during use causing the failure of the knuckle assembly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017522-2014-00015 |
| MDR Report Key | 4307650 |
| Report Source | 08 |
| Date Received | 2014-11-25 |
| Date of Report | 2014-10-30 |
| Date of Event | 2014-10-30 |
| Date Mfgr Received | 2014-10-30 |
| Device Manufacturer Date | 2010-05-01 |
| Date Added to Maude | 2014-12-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | FRANK RAY, MANAGER |
| Manufacturer Street | 11727 FRUEHAUF DR. |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal | 28273 |
| Manufacturer Phone | 7045877227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HELIOS 3000 WALL MOUNTED LIGHT |
| Generic Name | DENTAL OPERATING LIGHT |
| Product Code | EAZ |
| Date Received | 2014-11-25 |
| Model Number | HL3WL |
| Catalog Number | HL3WL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PELTON & CRANE |
| Manufacturer Address | 11727 FRUEHAUF DR. CHARLOTTE NC 28273 US 28273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-25 |