MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-12-19 for VACURETTE CURRETTE 12MM * manufactured by Gyrus Medical, Inc..
[18374958]
During a suction d&c, the tip of the vacurette broke during the procedure. When the vacurette was removed from the patient, the tip was broken but still attached. Approximately 1mm piece was broken at the tip but still attached. The surgical technician broke the piece off when examining the product. Difficult procedure with abnormal anatomy per doctor. Ultrasound to the room during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1275564 |
| MDR Report Key | 1275564 |
| Date Received | 2008-12-19 |
| Date of Report | 2008-12-19 |
| Date of Event | 2008-12-16 |
| Report Date | 2008-12-19 |
| Date Reported to FDA | 2008-12-19 |
| Date Added to Maude | 2009-01-02 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | VACURETTE CURRETTE 12MM |
| Generic Name | VACURETTE, CURVED |
| Product Code | HHK |
| Date Received | 2008-12-19 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 07083808 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS MEDICAL, INC. |
| Manufacturer Address | 6655 WEDGWOOD ROAD, SUITE 160 MAPLE GROVE MN 55311360 US 55311 3602 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-12-19 |