MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-12-07 for GYNECARE X-TRACT MORCELLATOR DV0015 manufactured by Ethicon, Inc..
[553491]
It was reported that the pt underwent a laparoscopic supracervical hysterectomy in 2006. During the procedure, the blade on the disposable tissue morcellator would not retract. They replaced the device and completed the case with no adverse pt consequences.
Patient Sequence No: 1, Text Type: D, B5
[8056383]
H-6 conclusion: the product upon which this medwatch is based is anticipated. Once the product is received, any further info derived from the eval will be submitted in a supplemental 3500a form.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2006-00824 |
| MDR Report Key | 794634 |
| Report Source | 06 |
| Date Received | 2006-12-07 |
| Date of Report | 2006-11-10 |
| Date of Event | 2006-11-08 |
| Date Facility Aware | 2006-11-08 |
| Report Date | 2006-11-10 |
| Date Mfgr Received | 2006-11-10 |
| Date Added to Maude | 2006-12-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LUIS BLANCO |
| Manufacturer Street | ROUTE 22 WEST, PO BOX 151 |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082183002 |
| Manufacturer G1 | ACCELLENT |
| Manufacturer Street | 45 LEXINGTON DR |
| Manufacturer City | LACONIA NH 03246 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03246 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GYNECARE X-TRACT MORCELLATOR |
| Generic Name | MORCELLATOR |
| Product Code | HFG |
| Date Received | 2006-12-07 |
| Model Number | NA |
| Catalog Number | DV0015 |
| Lot Number | MS0806046 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 782255 |
| Manufacturer | ETHICON, INC. |
| Manufacturer Address | * SOMERVILLE NJ 088760151 US |
| Baseline Brand Name | GYNECARE LAPAROSCOPIC MORCELLATOR |
| Baseline Generic Name | LAPAROSCOPIC MORCELLATOR |
| Baseline Model No | NA |
| Baseline Catalog No | DV0015 |
| Baseline ID | NA |
| Baseline Device Family | GYNECARE LAPAROSCOPIC MORCELLATOR |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K963872 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-12-07 |