MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-01-21 for GOLD LASER LF 20 "GOLD" LASER manufactured by Medical Energy, Inc..
[19903531]
Using a gold laser system -lf 20- to perform t&a. Inserted laser transnasally to ablate adenoids and noted very small ball tip -2. 3mm- of the laser wand was missing. Attempts made to find the tip including nasal endoscopy, direct laryngoscopy, straining suction apparatus contents, and evaluating pathology material were unsuccessful. Called company - rep for laser center indicated the tip is inert and not radiopaque, therefore, untraceable. Stated in the past, when tips had broken, there were no long term problems. Stated if it was in the nose or nasopharynx, it would work its way out. Surgeon did not see tip on repeat diligent exams. Diagnosis or reason for use: t & a. Event abated after use stopped or dose reduced: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5009684 |
| MDR Report Key | 1293920 |
| Date Received | 2009-01-21 |
| Date of Report | 2009-01-21 |
| Date of Event | 2009-01-20 |
| Date Added to Maude | 2009-02-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GOLD LASER |
| Generic Name | LIGHTFORCE LF20 |
| Product Code | EWG |
| Date Received | 2009-01-21 |
| Model Number | LF 20 "GOLD" LASER |
| Lot Number | 3028A |
| Device Expiration Date | 2009-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL ENERGY, INC. |
| Manufacturer Address | 8806 PAUL STARR DRIVE PENSACOLA FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-01-21 |