MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-08-28 for L300 SURGICAL ILLUMINATOR 90123 manufactured by Integra Burlington, Ma Inc..
[15507731]
Customer initially reports the unit was involved in an incident. The lamp literally exploded taking out the reflectors. Some parts were replaced by biomedical department in an attempt to repair the unit. On (b)(4) 2012, biomedical dept and surgical equipment tech report no real "explosion", the device smoked and the device lamp and both reflectors were significantly damaged. This occurred during "back" surgery and there was no harm to pt or staff. Device was quickly replaced and there was no real downtime.
Patient Sequence No: 1, Text Type: D, B5
[15691690]
To date the device involved in the reported incident has not been received for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222895-2012-00025 |
| MDR Report Key | 2719410 |
| Report Source | 06 |
| Date Received | 2012-08-28 |
| Date of Report | 2012-08-28 |
| Date Mfgr Received | 2012-08-21 |
| Date Added to Maude | 2012-12-14 |
| 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 Contact | SANDRA LEE |
| Manufacturer Street | 315 ENTERPRISE DR. |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | L300 SURGICAL ILLUMINATOR |
| Generic Name | COGENT 270 SURGICAL ILLUMINATOR |
| Product Code | FSW |
| Date Received | 2012-08-28 |
| Catalog Number | 90123 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA BURLINGTON, MA INC. |
| Manufacturer Address | BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-28 |