MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-03-21 for YASARGIL INSTRUMENT, ARACHNOID KNIFE * 277-217 manufactured by *.
[826448]
The user facility reported, that the tip of the yasargil arachnoid knife broke off and the tip was not recovered. Further conversation with the or nurse, who was in the room during the surgical procedure (anterior cervical discestomy and fusion) revealed that c-arm fluoroscopy was used for real-time anterior-posterior and lateral (ap and lateral) views of the operative site. The tip of the medical device was not located during this examination. The floor was swept with a magnet and the conte.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2430952-2008-00005 |
| MDR Report Key | 1023223 |
| Date Received | 2008-03-21 |
| Date of Report | 2008-03-21 |
| Date of Event | 2008-02-13 |
| Date Facility Aware | 2008-02-13 |
| Report Date | 2008-03-21 |
| Date Added to Maude | 2008-04-04 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | YASARGIL INSTRUMENT, ARACHNOID KNIFE |
| Generic Name | MICROSURGICAL INSTRUMENT |
| Product Code | GZX |
| Date Received | 2008-03-21 |
| Model Number | * |
| Catalog Number | 277-217 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 989459 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-03-21 |