MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-04-02 for CURETTE 628720 manufactured by Karl Storz.
[827923]
Two separate instruments broke during use in sinus surgery. One was a curette and the other was a grasper/cutter (with the moving part "jaw" that broke off).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5006118 |
| MDR Report Key | 1025018 |
| Date Received | 2008-03-21 |
| Date of Report | 2008-03-20 |
| Date of Event | 2008-03-03 |
| Date Added to Maude | 2008-04-14 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CURETTE |
| Generic Name | NONE |
| Product Code | FZS |
| Date Received | 2008-04-02 |
| Catalog Number | 628720 |
| Lot Number | GH 01 |
| Operator | HEALTH PROFESSIONAL |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 992494 |
| Manufacturer | KARL STORZ |
| Brand Name | GRASPER |
| Generic Name | NONE |
| Product Code | GEN |
| Date Received | 2008-04-02 |
| Catalog Number | RH551-091 |
| Operator | HEALTH PROFESSIONAL |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 2 |
| Device Event Key | 992495 |
| Manufacturer | V. MULLER VINE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-03-21 |