MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-07-17 for "SURCH-LITE" NS15 manufactured by Aaron Medical Industries.
[248842]
Light bulb and holder separated from device used by anesthesia. Bronchoscopy done to remove the metal tip of the "surch-lite" from the main stem bronchus of right lung.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 405937 |
| MDR Report Key | 405937 |
| Date Received | 2002-07-17 |
| Date of Report | 2002-07-12 |
| Date of Event | 2002-06-24 |
| Date Facility Aware | 2002-06-24 |
| Report Date | 2002-07-02 |
| Date Reported to Mfgr | 2002-07-09 |
| Date Added to Maude | 2002-07-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | "SURCH-LITE" |
| Generic Name | 15" NON-STERILE FLEXIBLE LIGHT |
| Product Code | FTF |
| Date Received | 2002-07-17 |
| Model Number | NS15 |
| Catalog Number | NS15 |
| Lot Number | NA |
| ID Number | NON-STERILE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 394926 |
| Manufacturer | AARON MEDICAL INDUSTRIES |
| Manufacturer Address | 7100 30TH AVE. NORTH ST. PETERSBURG FL 33710 US |
| Baseline Brand Name | AARON MEDICAL |
| Baseline Generic Name | FLEXIBLE ILLUMINATOR |
| Baseline Model No | NA |
| Baseline Catalog No | NS15 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K840372 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-07-17 |