MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-25 for UNKNOWN manufactured by Unknown.
[1232]
Pituitary rongeur being used intraoperatively to remove spinal disc. One tip of the mouth of the rongeur was noted to be missing when rongeur removed from surgical wound. Tip retained by disc space. A second rongeur was used to remove retained portion in its entiretydevice 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, visual examination. Results of evaluation: expected wear/deterioration. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: maybe. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2392 |
| MDR Report Key | 2392 |
| Date Received | 1993-01-25 |
| Date of Report | 1992-12-28 |
| Date of Event | 1992-12-14 |
| Date Facility Aware | 1992-12-14 |
| Report Date | 1992-12-28 |
| Date Reported to FDA | 1992-12-28 |
| Date Added to Maude | 1993-02-08 |
| 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 | UNKNOWN |
| Generic Name | PITUITARY RONGEUR |
| Product Code | EMH |
| Date Received | 1993-01-25 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 2218 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-01-25 |