MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-09 for CONSOLE COMMAND SYSTEM NONE 5D-296-10-40K manufactured by Stryker Instruments.
[2196]
In the process of doing oral surgery, thge distal portion of the handpiece (burr holder) became hot and burned patient. Injury assessed by a physician consultant and burn treatment starteddevice 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-aug-91. 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, performance tests performed. Results of evaluation: component failure, telemetry failure, none or unknown, component failure. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3211 |
| MDR Report Key | 3211 |
| Date Received | 1992-07-09 |
| Date of Report | 1992-03-23 |
| Date of Event | 1992-03-17 |
| Date Facility Aware | 1992-03-17 |
| Report Date | 1992-03-23 |
| Date Reported to Mfgr | 1992-03-17 |
| Date Added to Maude | 1993-04-12 |
| 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 | CONSOLE COMMAND SYSTEM |
| Generic Name | SURGICAL DRILL |
| Product Code | HBD |
| Date Received | 1992-07-09 |
| Model Number | NONE |
| Catalog Number | 5D-296-10-40K |
| Lot Number | NONE |
| ID Number | 28864 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | 01-JUL-91 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 2995 |
| Manufacturer | STRYKER INSTRUMENTS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-07-09 |