MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2006-08-25 for GYNECARE X-TRACT MORCELLATOR DV0015 manufactured by Ethicon, Inc..
[498021]
It was reported that the patient underwent a laparoscopic splenectomy and a laparoscopic cholescystotomy in 2006. In this case, one consultant physician, with morcellator experience, was supervising another consultant physician, who was operating the morcellator for the first time. The procedure began at 2pm and the spleen was removed first under laparoscopic vision. The morcellator handle was inserted to remove the spleen. At 4pm, the anesthetist noticed there was a problem with the patient's vital signs, as the heart rate was increasing and the blood pressure was decreasing. The consultant was alerted that the patient was having a cardiac arrest and cardiopulmonary resuscitation (cpr) began immediately. The consultants, unsure of the cause of the arrest, performed a laparotomy to find that a "tear", not a "cut", was present on both the abdominal aorta and on the colon. Both injuries were considered "minor" at the time and they were both quickly repaired. The patient stabilized for a short time and the surgeons decided to abandon the laparoscopic cholescystotomy procedure. The patient began to deteriorate, cardiac arrested a second time on the operating table, and cpr was performed. Cpr was abandoned at 5:50pm and the patient was deemed deceased. Because the circulatory changes were not "visually associated" with significant blood loss, the immediate intra-operative assessment of the underlying cause of the patient's "catastrophic consequence" was "air emboli". The total blood loss during the entire procedure was estimated at 25%, but it was quickly replaced and was not considered a cause of patient death. The post mortem findings show the two sufficiently repaired injuries to the aorta and the colon. The injuries are not considered the direct cause of death. The official cause of death has not been declared. It cannot be determined if the injury was from the morcellator.
Patient Sequence No: 1, Text Type: D, B5
[7834030]
Conclusion: no conclusion can be drawn at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2006-00571 |
| MDR Report Key | 754050 |
| Report Source | 01,05,06,07 |
| Date Received | 2006-08-25 |
| Date of Report | 2006-07-28 |
| Date of Event | 2006-07-27 |
| Date Facility Aware | 2006-07-27 |
| Report Date | 2006-07-28 |
| Date Mfgr Received | 2006-07-28 |
| Date Added to Maude | 2006-08-25 |
| 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 P.O. BOX 151 |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082183002 |
| Manufacturer G1 | ACCELLENT |
| 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 | 2006-08-25 |
| Model Number | NA |
| Catalog Number | DV0015 |
| Lot Number | MS0805070 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 741868 |
| Manufacturer | ETHICON, INC. |
| Manufacturer Address | * SOMERVILLE NJ 088760151 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2006-08-25 |