MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-02-18 for MEDLITE C6 659-0002 manufactured by Hoya Conbio.
[346288]
The medlite c6 was in the warm up sequence and omitted an unexpected single shot of laser energy. The root cause has not been determined and is currently undergoing evaluation. It is thought that a random noise event caused the external output shutter to open. The source of the noise is unknown and the system has been tested to all the necessary emc immunity requirements. The shutter monitor did detect the open shutter condition and shut the system down and displayed the approriate error 12. This response limited the exposure to a single shot of energy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2918486-2004-00002 |
| MDR Report Key | 578918 |
| Report Source | 06 |
| Date Received | 2005-02-18 |
| Date of Report | 2005-02-17 |
| Date of Event | 2004-09-16 |
| Date Mfgr Received | 2004-09-20 |
| Device Manufacturer Date | 2003-01-01 |
| Date Added to Maude | 2005-03-09 |
| 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 | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDLITE C6 |
| Generic Name | ND: YAG Q-SWITCHED PULSED LASER SYSTEM |
| Product Code | LXS |
| Date Received | 2005-02-18 |
| Model Number | MEDLITE C6 |
| Catalog Number | 659-0002 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 568765 |
| Manufacturer | HOYA CONBIO |
| Manufacturer Address | 47733 FREMONT BLVD. FREMONT CA 94538 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. Other | 2005-02-18 |