MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-10-09 for 765DC INTRAORAL X-RAY 110-0155G1 A0765DC75 manufactured by Gendex Dental Systems.
[954117]
The dental technician went to position the tubehead to the patient, and the tubehead yoke cracked. The patient caught the tubehead.
Patient Sequence No: 1, Text Type: D, B5
[8230457]
There was no patient or user injury with this event. Results - the tubehead yoke cracked in half, in the middle of the yoke graphics panel. The yoke is a curved metal section that connects the tubehead to the scissor arm assembly. A wiring harness that runs through the yoke and the arm, connects to the tubehead and to the converter (master control) assembly. The wiring harness is approximately two to three inches long at the tubehead. Conclusions - the articulated arm has been replaced.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004115000-2008-00015 |
| MDR Report Key | 1197785 |
| Report Source | 05,06 |
| Date Received | 2008-10-09 |
| Date of Report | 2008-09-10 |
| Date of Event | 2008-09-10 |
| Date Mfgr Received | 2008-09-10 |
| Device Manufacturer Date | 2004-09-08 |
| Date Added to Maude | 2009-09-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARI LAMBERT, MANAGER |
| Manufacturer Street | 901 W. OAKTON |
| 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 | 765DC INTRAORAL X-RAY |
| Generic Name | DETNAL X-RAY EQUIPMENT |
| Product Code | EAP |
| Date Received | 2008-10-09 |
| Model Number | 110-0155G1 |
| Catalog Number | A0765DC75 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENDEX DENTAL SYSTEMS |
| Manufacturer Address | 901 W. OAKTON DES PLAINES IL 60018 US 60018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-09 |