MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-10 for BIRTCHER 4400 NA manufactured by Birtcher Medical Systems, Inc..
[19077283]
Patient was to have two lesions removed from back. During removal of first lesion, there was arcing from electrosurgical unit, then a flame in the area. Procedure terminated. Ice placed on back where flames had been. Appeared to be a 6-10 cm. Area of 1 st and 2 nd degree burns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 24987 |
| MDR Report Key | 24987 |
| Date Received | 1995-01-10 |
| Date of Report | 1994-05-26 |
| Date of Event | 1994-05-12 |
| Date Facility Aware | 1994-05-16 |
| Report Date | 1994-05-26 |
| Date Reported to Mfgr | 1994-05-26 |
| Date Added to Maude | 1995-08-28 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | BIRTCHER |
| Generic Name | ELECTROSURGICAL UNIT |
| Product Code | FAR |
| Date Received | 1995-01-10 |
| Model Number | 4400 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 21 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 25425 |
| Manufacturer | BIRTCHER MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 50 TECHNOLOGY DRIVE IRVINE CA 927182301 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 1995-01-10 |