MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-05-10 for GX-770 0.820.0146 manufactured by Gendex Dental Systems.
[145776169]
The unit has not been returned to the manufacturer for evaluation. A cause as to the malfunction of the unit component cannot be determined. The gx-770 was discontinued from sale on (b)(6) 2010 and the manufacturer support of the device ended on (b)(6) 2017. This concludes the investigation.
Patient Sequence No: 1, Text Type: N, H10
[145776170]
It was reported that the gx-770 tubehead broke loose and fell off the shaft and was hanging by its wires. The hygienist was wiping down the device when the device came apart and the unit fell against the wall and was laying on the counter top. There was no report of operator or patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530069-2019-00003 |
| MDR Report Key | 8601450 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-05-10 |
| Date of Report | 2019-05-10 |
| Date of Event | 2019-04-16 |
| Date Mfgr Received | 2019-04-19 |
| Device Manufacturer Date | 2005-07-01 |
| Date Added to Maude | 2019-05-10 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ERIKA MARTIN |
| Manufacturer Street | 1910 NORTH PENN ROAD |
| Manufacturer City | HATFIELD PA 19440 |
| Manufacturer Country | US |
| Manufacturer Postal | 19440 |
| Manufacturer G1 | GENDEX DENTAL SYSTEMS |
| Manufacturer Street | 1910 NORTH PENN ROAD |
| Manufacturer City | HATFIELD PA 19440 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19440 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GX-770 |
| Generic Name | UNIT, X-RAY, EXTRAORAL WITH TIMER |
| Product Code | EHD |
| Date Received | 2019-05-10 |
| Model Number | GX-770 |
| Catalog Number | 0.820.0146 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENDEX DENTAL SYSTEMS |
| Manufacturer Address | 1910 NORTH PENN ROAD HATFIELD PA 19440 US 19440 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-10 |