MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2019-01-11 for GYNECARE X-TRACT MORCELLATOR UNKNOWN PRODUCT GYNXMCUNK manufactured by Ethicon Inc..
[132904676]
(b)(4). To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent. It is unknown if the actual device used in this patient procedure was in fact an ethicon morcellator. The event investigation is ongoing. Attempts are being made to obtain the additional information. To date no response has been provided. If further details are received at the later date a supplemental medwatch will be sent. How are you currently feeling? If in your possession, may we have a copy of your operative report? Does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? If so, please provide your surgeon? S name, contact information and sign release of medical information form attached. Note: patient-reported adverse event of abdominal tumor diagnosed in 2014, abdominal open incision surgery for removal of the mass and leiomyoma as pathology results was reported via 2210968-2019-78354. Patient-reported adverse event of the new diagnosis which requires an open incision abdominal surgery with removal of cervix, fallopian tubes, ovaries, lymph nodes, appendix along with recession of bowels was reported via 2210968-2019-78366. The device information for use under precautions states" caution: the use of a laparoscopic tissue extraction bag is recommended for the morcellation of malignant tissue or tissue suspected of being malignant and for tissue that the physician considers to be potentially harmful when disseminated in a body cavity. As morcellation may affect endometrial pathologic examination, preoperative evaluation of the endometrium should be considered. Should malignancy be identified, use of the gynecare morcellex? Tissue morcellator may lead to dissemination of malignant tissue.
Patient Sequence No: 1, Text Type: N, H10
[132904677]
It was reported that the patient underwent a laparoscopic hysterectomy in 2006 and the morcellator was used. In 2014, the patient was diagnosed with an abdominal tumor and underwent an abdominal open incision surgery for removal of the mass. The pathologist report results were leiomyoma. In (b)(6) 2018, the patient was diagnosed with three abdominal tumors. Another open incisional surgery is scheduled, and primary diagnosis is disseminated leiomyomatosis. It was also reported that after the hysterectomy, ct scan shows that most of masses are located at the port site areas. The new diagnosis requires an open incision abdominal surgery with removal of cervix, fallopian tubes, ovaries, lymph nodes, appendix along with recession of bowels. The physician opined that the patient's tumors are the result of the morcellator. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-78367 |
| MDR Report Key | 8242653 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2019-01-11 |
| Date of Report | 2018-12-20 |
| Date of Event | 2018-11-09 |
| Date Mfgr Received | 2019-03-05 |
| Date Added to Maude | 2019-01-11 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DARLENE KYLE |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182792 |
| Manufacturer G1 | ETHICON INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GYNECARE X-TRACT MORCELLATOR UNKNOWN PRODUCT |
| Generic Name | LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) |
| Product Code | HET |
| Date Received | 2019-01-11 |
| Catalog Number | GYNXMCUNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-11 |