MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-06-08 for ENDOLAP 003.4 manufactured by Endolap, Inc.
[18554828]
Delivery end of the cord is a light carrier and it sticks out over the coupler end by about 3-4mm. The light cord was laid on a towel in a sterile field and when it was turned on, within seconds, the towel caught fire. Rptr states that a competitor makes the same type of cord which has a cover guard for the end. Rptr believes that if device had this guard the fire would not have started. Mfr was notified about event and is investigating.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1019080 |
| MDR Report Key | 280907 |
| Date Received | 2000-06-08 |
| Date of Report | 2000-06-08 |
| Date of Event | 2000-06-08 |
| Date Added to Maude | 2000-06-09 |
| 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 | 0 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOLAP |
| Generic Name | FIBEROPTIC LIGHT CORD 0.4MM X 10FT |
| Product Code | EQH |
| Date Received | 2000-06-08 |
| Model Number | NA |
| Catalog Number | 003.4 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 271859 |
| Manufacturer | ENDOLAP, INC |
| Manufacturer Address | 3012 MERCY DR ORLANDO FL 32808 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-06-08 |