MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-02-15 for ELECTROSURGICAL COAGULATION SUCTION TUBE W/STYLET 809610 manufactured by Edward Weck, Inc..
[1324]
Flash fire occurred in oral cavity-flames were simutaneously extinguished. Cautery was removed stat from field and cautery machine disconnected. Patient was extubated and intubated per anesthesia. In pacu, a small burn was noted on left lateral aspect of tongue. Examined by dr. , no treatment neededdevice 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, visual examination. Results of evaluation: telemetry failure. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: other. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2442 |
| MDR Report Key | 2442 |
| Date Received | 1993-02-15 |
| Date of Report | 1993-02-03 |
| Date of Event | 1993-01-26 |
| Date Facility Aware | 1993-01-26 |
| Report Date | 1993-02-03 |
| Date Reported to FDA | 1993-02-03 |
| Date Reported to Mfgr | 1993-01-26 |
| Date Added to Maude | 1993-03-08 |
| 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 | ELECTROSURGICAL COAGULATION SUCTION TUBE W/STYLET |
| Product Code | EKZ |
| Date Received | 1993-02-15 |
| Catalog Number | 809610 |
| Lot Number | 809610 2H1566 |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 2268 |
| Manufacturer | EDWARD WECK, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-02-15 |