MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-02-02 for REUSABLE ELECTRODE EXTENDER SAME 138026 manufactured by Birtcher Medical Systems, Inc..
[2244]
Forty-eight year old woman in good condition to or for left breast revision reconstruction. During the procedure while the physician was caauterizating using the extension, a spark ocurred causing a burn at the cautery szite. The burned area ws excised. The extender was examined for cracks in the insulation and none was founddevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, other. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: maybe. Corrective actions: device permanently removed from service, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3856 |
| MDR Report Key | 3856 |
| Date Received | 1993-02-02 |
| Date of Report | 1992-12-01 |
| Date of Event | 1992-11-27 |
| Date Facility Aware | 1992-11-27 |
| Report Date | 1992-12-01 |
| Date Reported to FDA | 1992-12-01 |
| Date Reported to Mfgr | 1992-12-01 |
| Date Added to Maude | 1993-05-06 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REUSABLE ELECTRODE EXTENDER |
| Generic Name | ELECTROCAUTERY EXTENSION |
| Product Code | HIM |
| Date Received | 1993-02-02 |
| Model Number | SAME |
| Catalog Number | 138026 |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 3596 |
| Manufacturer | BIRTCHER MEDICAL SYSTEMS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-02-02 |