MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2001-05-31 for CLEARCUT KNIFE 8065-9932-45 manufactured by Alcon Precision Device - Sinking Spring.
[245635]
A surgeon reported that the last few knives he used seemed dull. No patient impact/injury was associated with this report. The surgeon stated the dullness of the knives could result in injury if too much pressure were needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523835-2001-00001 |
| MDR Report Key | 336137 |
| Report Source | 05,06 |
| Date Received | 2001-05-31 |
| Date of Report | 2001-05-02 |
| Report Date | 2001-05-02 |
| Date Mfgr Received | 2001-05-02 |
| Device Manufacturer Date | 2000-11-01 |
| Date Added to Maude | 2001-06-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | CHUCK DOLBEE |
| Manufacturer Street | 6201 SOUTH FREEWAY |
| Manufacturer City | FORT WORTH TX 761342099 |
| Manufacturer Country | US |
| Manufacturer Postal | 761342099 |
| Manufacturer Phone | 8175518317 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLEARCUT KNIFE |
| Generic Name | KNIFE |
| Product Code | EMF |
| Date Received | 2001-05-31 |
| Returned To Mfg | 2001-05-02 |
| Model Number | NA |
| Catalog Number | 8065-9932-45 |
| Lot Number | 530717M |
| ID Number | NA |
| Device Expiration Date | 2005-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 325461 |
| Manufacturer | ALCON PRECISION DEVICE - SINKING SPRING |
| Manufacturer Address | 714 COLUMBIA AVE. SINKING SPRING PA 19608 US |
| Baseline Brand Name | CLERCUT KNIFE |
| Baseline Generic Name | KNIFE |
| Baseline Model No | NA |
| Baseline Catalog No | 8065-9932-45 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-05-31 |