MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-08-23 for GYNECARE X-TRACT * DV0015 manufactured by Ethicon, Inc..
[386853]
During procedure the attending physician noted that the gynecare morcellator would not oscillate. Another package was opened and that morcellator would not work either. A third package was opened and that device worked properly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 633811 |
| MDR Report Key | 633811 |
| Date Received | 2005-08-23 |
| Date of Report | 2005-08-23 |
| Date of Event | 2005-08-15 |
| Report Date | 2005-08-23 |
| Date Reported to FDA | 2005-08-23 |
| Date Added to Maude | 2005-09-12 |
| 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 | GYNECARE X-TRACT |
| Generic Name | TISSUE MORCELLATOR |
| Product Code | HFG |
| Date Received | 2005-08-23 |
| Model Number | * |
| Catalog Number | DV0015 |
| Lot Number | MS0705051 |
| ID Number | * |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 623383 |
| Manufacturer | ETHICON, INC. |
| Manufacturer Address | ROUTE 22 WEST P.O. BOX 151 SOMERVILLE NJ 088760151 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-08-23 |