MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-01-31 for GYNECARE X-TRACT TISSUE MORCELLATOR 4151 * manufactured by Ethicon Inc..
[373205]
Morcellator used for procedure. At end of procedure the disposable morcellating device that fits onto the gynecare driver appeared to have leaked oil all over the glove of the scrub tech that was holding the device. There was no spillage into the patient, but the glove was covered with what appeared to be black grease. All other devices of the same lot number were pulled from the shelves.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 573064 |
| MDR Report Key | 573064 |
| Date Received | 2005-01-31 |
| Date of Report | 2005-01-31 |
| Date of Event | 2005-01-19 |
| Report Date | 2005-01-31 |
| Date Reported to FDA | 2005-01-31 |
| Date Added to Maude | 2005-02-17 |
| 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 | GYNECARE X-TRACT TISSUE MORCELLATOR |
| Product Code | HFG |
| Date Received | 2005-01-31 |
| Model Number | 4151 |
| Catalog Number | * |
| Lot Number | MS0404048 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 562932 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | ROUTE 22 PO BOX 151 SOMERVILLE NJ 08876 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-01-31 |