MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-29 for ELECTRICOSURGICAL UNIT FORCE 4B manufactured by Valleylab Inc. A Pfizer Co..
[6904]
Superfical burn on left heel. Patient leg was raised and accidently placed on esu pencil and activated. Device not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-jul-93. Service provided by: user facility biomedical/bioengineering department. Service records available. 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, electrical tests performed, performance tests performed, visual examination. Results of evaluation: none or unknown, none or unknown, incorrect technique/procedure. Conclusion: user error caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: user education provided. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9064 |
| MDR Report Key | 9064 |
| Date Received | 1994-07-29 |
| Date of Report | 1994-03-04 |
| Date of Event | 1994-02-23 |
| Date Facility Aware | 1994-02-23 |
| Report Date | 1994-03-04 |
| Date Reported to Mfgr | 1994-03-04 |
| Date Added to Maude | 1994-11-23 |
| 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 | 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 | ELECTRICOSURGICAL UNIT |
| Generic Name | ESU, BOVIE, CARTERY |
| Product Code | FAR |
| Date Received | 1994-07-29 |
| Model Number | FORCE 4B |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 8724 |
| Manufacturer | VALLEYLAB INC. A PFIZER CO. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-07-29 |