FDA.reportPublic FDA data

MAUDE MDR 8242646

MDR report key
8242646
Report number
2210968-2019-78366
Event key
0
Event type
3
Date received
2019-01-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Contact
DARLENE KYLE
Address
P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US
Phone
908-908-9082
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GYNECARE X-TRACT MORCELLATOR UNKNOWN PRODUCTLAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)ETHICON INC.HETGYNXMCUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-1101. R

Event Narratives#

N

Patient 1

(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. 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.

D

Patient 1

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. ADDITIONAL INFORMATION HAS BEEN REQUESTED.