MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-02-07 for MEDLITE C6 659-0020 manufactured by Hoya Conbio.
[568372]
Tattoo remover was treating a tattoo and switched the laser wavelength from 1064 nm to 650 nm by attaching the 650 nm dye conversion handpiece to the end of the articulated arm. She had the pt change the laser safety eyewear to the correct 650 nm glasses, but forgot to change her eyewear to the correct wavelength. When she stepped on the foot switch, she noticed that the 650 nm light was very bright and immediately stopped the laser by releasing the foot switch. She indicates that she saw about 5 flashes before stopping the treatment. After this, she experienced a head ache but had no problems with her vision. I advised her to see a physician to examine her eyes for evidence of damage to the eye. She indicates that the ophthalmologist found no damage and her head ache went away the following day.
Patient Sequence No: 1, Text Type: D, B5
[8058122]
Rptr acknowledges that she forgot to change her eyewear to the correct wavelength. She indicates that she was trained on the use of the laser and that the instruction included the necessity to change the eyewear when using the polymer dye conversion handpieces. The manual clearly states in several places to wear the correct eyewear when installing the dye conversion handpieces. The adverse event was not caused by a failure of the system or from inadequate training or instructions for use and hence no corrective action is being taken or is necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2918486-2007-00001 |
| MDR Report Key | 817335 |
| Report Source | 05 |
| Date Received | 2007-02-07 |
| Date of Report | 2007-02-07 |
| Date of Event | 2007-01-03 |
| Date Mfgr Received | 2007-01-03 |
| Device Manufacturer Date | 2005-12-01 |
| Date Added to Maude | 2007-02-15 |
| 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 | 0 |
| Manufacturer Contact | JIM GREEN |
| Manufacturer Street | 47733 FREMONT BLVD |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal | 94538 |
| Manufacturer Phone | 5104454528 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDLITE C6 |
| Generic Name | Q-SWITCHED ND:YAG LASER WITH POLYMER DYE |
| Product Code | LXS |
| Date Received | 2007-02-07 |
| Model Number | MEDLITE C6 |
| Catalog Number | 659-0020 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 804818 |
| Manufacturer | HOYA CONBIO |
| Manufacturer Address | * FREMONT CA * US |
| Baseline Brand Name | MEDLITE C6 |
| Baseline Generic Name | ND: YAG Q-SWITCHED PULSED LASER SYSTEM |
| Baseline Model No | MEDLITE C6 |
| Baseline Catalog No | 659-0002 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2007-02-07 |