MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-05-16 for GRIESHABER KNIFE * 681.05 manufactured by Alcon Laboratories, Inc..
[16407839]
Doctor noticed the tip of grieshaber knife was bent when it was examined under the microscope. Knife was not used and a new one was obtained. Procedure was delayed one minute while new knife opened. No injuries were reported to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 722458 |
| MDR Report Key | 722458 |
| Date Received | 2006-05-16 |
| Date of Report | 2006-05-16 |
| Date of Event | 2006-03-01 |
| Report Date | 2006-05-16 |
| Date Reported to FDA | 2006-05-16 |
| Date Added to Maude | 2006-06-06 |
| 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 | 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 | GRIESHABER KNIFE |
| Generic Name | SCALPEL, DISPOSABLE |
| Product Code | GDX |
| Date Received | 2006-05-16 |
| Model Number | * |
| Catalog Number | 681.05 |
| Lot Number | F52473 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 711525 |
| Manufacturer | ALCON LABORATORIES, INC. |
| Manufacturer Address | 6201 SOUTH FREEWAY; MAIL STOP FORT WORTH TX 76134 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-05-16 |