MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-04-04 for GX770 INTRAORAL X-RAY 46-404600G6 A0770JT manufactured by Gendex Dental Systems.
[827830]
The doctor complained of light x-ray images.
Patient Sequence No: 1, Text Type: D, B5
[8026432]
Results: the light images are caused by not enough output from the tubehead which creates light gray images instead of crisp clear images. Routine electrical safety testing calibration was performed on the unit and found that the unit is operational and within calibration. Tubehead was checked for leakage and leakage was present, coming from the back of the tubehead. Conclusions: there is a lead sheath that is placed in the tubehead that blocks the radiation from coming out the back of the tubehead. The technician stated that this sheath is 1/16" and there is a possibility that there is a rip in the sheath or that the sheath was not installed in the tubehead. Tubehead is being replaced. Investigation ongoing to determine root cause.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004115000-2008-00006 |
| MDR Report Key | 1025428 |
| Report Source | 06 |
| Date Received | 2008-04-04 |
| Date of Report | 2008-03-05 |
| Date of Event | 2008-03-05 |
| Date Mfgr Received | 2008-03-05 |
| Device Manufacturer Date | 2001-12-03 |
| Date Added to Maude | 2008-07-11 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARI LAMBERT, |
| Manufacturer Street | 901 WEST OAKTON ST. |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 8473643958 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GX770 INTRAORAL X-RAY |
| Generic Name | DENTAL X-RAY EQUIPMENT |
| Product Code | EAP |
| Date Received | 2008-04-04 |
| Model Number | 46-404600G6 |
| Catalog Number | A0770JT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1023636 |
| Manufacturer | GENDEX DENTAL SYSTEMS |
| Manufacturer Address | 901 WEST OAKTON DES PLAINES IL 60018 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-04 |