MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-01-15 for GYNECARE MORCELLEX UNKNOWN PRODUCT GMORCUNK manufactured by Ethicon Inc..
[185892171]
(b)(4). No conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly. 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. It is unknown if the actual device used in this patient procedure was in fact an ethicon morcellator. The event investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[185892172]
It was reported by an attorney that the patient underwent a robotic-assisted total laparoscopic hysterectomy procedure on (b)(6) 2014 and unknown morcellator was used. It was reported that the use of morcellator led to the development of leiomyosarcoma. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-00414 |
| MDR Report Key | 9594343 |
| Report Source | OTHER |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-13 |
| Date of Event | 2014-04-11 |
| Date Mfgr Received | 2020-01-13 |
| Date Added to Maude | 2020-01-15 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | ETHICON INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GYNECARE MORCELLEX UNKNOWN PRODUCT |
| Generic Name | LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) |
| Product Code | HET |
| Date Received | 2020-01-15 |
| Catalog Number | GMORCUNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-15 |