MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-10-11 for GYNECARE X-TRACT * DV0015 manufactured by Gynecare Worldwide - A Division Of Ethicon, Inc..
[405163]
Gynecare x-tract tissue morcellator stopped working in the middle of the case. Tried turning everything off and on and moving the connection around but the device still would not work. Replaced it with another morcellator and was able to finish the procedure. No injury to patient. Contacted representative to make arrangements to pick up device for testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 642078 |
| MDR Report Key | 642078 |
| Date Received | 2005-10-11 |
| Date of Report | 2005-10-11 |
| Date of Event | 2005-10-06 |
| Report Date | 2005-10-11 |
| Date Reported to FDA | 2005-10-11 |
| Date Added to Maude | 2005-10-22 |
| 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 | MORCELLATOR |
| Product Code | HFG |
| Date Received | 2005-10-11 |
| Model Number | * |
| Catalog Number | DV0015 |
| Lot Number | MS0905035 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 631605 |
| Manufacturer | GYNECARE WORLDWIDE - A DIVISION OF ETHICON, INC. |
| Manufacturer Address | P.O. BOX 151 SOMERVILLE NJ 08876 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-10-11 |