MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-06-11 for MICRO-MINIATURE LIGHT WIRE CUTTER ODG-1003 manufactured by Gac International.
[1398605]
It was reported that the tip of a micro-miniature light wire cutter became chipped during the sterilization process; no injury resulted.
Patient Sequence No: 1, Text Type: D, B5
[8604074]
While no serious injury resulted in this event, and thought the event occurred outside of a patient's mouth, there has been a previous report received in the past two years involving a similar device where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2086211-2010-00085 |
| MDR Report Key | 1726676 |
| Report Source | 06 |
| Date Received | 2010-06-11 |
| Date of Report | 2010-05-13 |
| Date of Event | 2010-05-13 |
| Date Mfgr Received | 2011-05-13 |
| Date Added to Maude | 2011-02-18 |
| 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 | HELEN LEWIS |
| Manufacturer Street | 221 W. PHILA. ST., STE. 60 |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | ORTHODENTAL INTL., INC. |
| Manufacturer Street | 2306 M.L. KING, SUITE 1 |
| Manufacturer City | CALEXICO CA 92231 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92231 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICRO-MINIATURE LIGHT WIRE CUTTER |
| Product Code | EJB |
| Date Received | 2010-06-11 |
| Catalog Number | ODG-1003 |
| Lot Number | 09-36 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAC INTERNATIONAL |
| Manufacturer Address | BOHEMIA NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-11 |