MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2009-07-27 for ART-E1 ELECTROSURGERY UNIT ART-EI NA manufactured by Bonart Co. Ltd..
[1267221]
On 04/2009, we were informed by our united states initial distributor and importer, (b) (4) that they had received a letter from the patient's lawyer dated 04/11/2009 stating that they had been in incident back on (b) (6) 2007 where patient was burned during a procedure by the dentist at this dental clinic while using the hand piece with blade option that was being claimed to have been included with the bonart's art-e1 electrosurgery unit.
Patient Sequence No: 1, Text Type: D, B5
[8268127]
Evaluation of devices within the same manufacturing and shipment batch did not reveal any kinds of malfunctions in design nor in operations. We had determined that our documentation and record on file did not show any mislabeling. It was a simple mixed up by our assembly personnel (human error) during the packaging process. Following actions have been in process: thorough review of our production and packaging procedures. Continuous personnel training. Recommended united states initial distributor and importer, (b) (4). Fda (b) (4) to forward immediate product alert notification to their customers about replacement to be sent out to any possible incorrect type of hand pieces that had come with this batch of shipment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9710363-2009-00001 |
| MDR Report Key | 1425438 |
| Report Source | 08 |
| Date Received | 2009-07-27 |
| Date of Report | 2009-07-20 |
| Date of Event | 2007-07-11 |
| Date Mfgr Received | 2009-04-17 |
| Device Manufacturer Date | 2006-12-12 |
| Date Added to Maude | 2010-02-19 |
| 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 Street | RM. 405, NO.3 WUCHUAN 1ST RD |
| Manufacturer City | HSINCHUANG, TAIPEI HSIEN |
| Manufacturer Country | TW |
| Manufacturer Phone | 222983980 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ART-E1 ELECTROSURGERY UNIT |
| Generic Name | DENTAL ELECTROSURGICAL UNIT & ACCESS. |
| Product Code | EKZ |
| Date Received | 2009-07-27 |
| Model Number | ART-EI |
| Catalog Number | NA |
| Lot Number | 12/13/2006 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BONART CO. LTD. |
| Manufacturer Address | HSINCHUANG, TAIPEI SHIEN TW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-07-27 |