MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-03-21 for GYNECARE X-TRACT TISSUE MORCELLATOR * manufactured by Gynecare Worldwire.
[442085]
Surgeon noted that the morcellator was not working. He felt it was not sharp enough.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 694876 |
| MDR Report Key | 694876 |
| Date Received | 2006-03-21 |
| Date of Report | 2006-03-21 |
| Date of Event | 2006-03-21 |
| Report Date | 2006-03-21 |
| Date Reported to FDA | 2006-03-21 |
| Date Added to Maude | 2006-04-05 |
| 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 TISSUE MORCELLATOR |
| Generic Name | MORCELLATOR |
| Product Code | LEC |
| Date Received | 2006-03-21 |
| Returned To Mfg | 2006-03-21 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | MS0106035 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 684005 |
| Manufacturer | GYNECARE WORLDWIRE |
| Manufacturer Address | A DIV. OF ETHICON, INC. P.O. BOX 151 SOMERVILLE NJ 08876 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-03-21 |