MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-08-18 for GYNECARE X-TRACT MORCELLATOR DV0015 manufactured by Ethicon, Inc..
[422214]
The pt underwent a splenectomy in 2005. During the procedure, the right iliac artery and left iliac vein were lacerated. Estimated blood loss was 5-6 liters, and the pt received multiple blood transfusions. The right iliac artery was repaired with a graft, the left iliac vein was ligated, and the pt has been discharged from the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2005-00498 |
| MDR Report Key | 628158 |
| Report Source | 05,06 |
| Date Received | 2005-08-18 |
| Date of Report | 2005-07-19 |
| Date of Event | 2005-07-19 |
| Date Facility Aware | 2005-07-19 |
| Report Date | 2005-07-19 |
| Date Mfgr Received | 2005-07-19 |
| Date Added to Maude | 2005-08-22 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MARK YALE |
| Manufacturer Street | ROUTE 22 WEST P.O. BOX 151 |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182326 |
| Manufacturer G1 | ACCELENT |
| Manufacturer Street | 45 LEXINGTON DRIVE |
| 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 | 2005-08-18 |
| Returned To Mfg | 2005-08-24 |
| Model Number | NA |
| Catalog Number | DV0015 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNK |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 617787 |
| Manufacturer | ETHICON, INC. |
| Manufacturer Address | P.O BOX 151, ROUTE 22 WEST 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 | 1. Hospitalization; 2. Life Threatening | 2005-08-18 |