MAUDE Adverse Event Report: ETHICON INC. GYNECARE MORCELLEX UNKNOWN PRODUCT; LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).It is unknown if the actual device used in this patient procedure was in fact an ethicon morcellator.The event investigation is ongoing.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.

Event Description

It was reported by the attorney that the patient underwent a myomectomy procedure on unknown date for infertility and the unknown morcellator was utilized.The procedure was prolonged with complications and intraoperative findings were notable for an atypical leiomyoma which was morcellated.Subsequently, the patient underwent a hysterectomy one -two years later.Pathology was reviewed several times and felt consistent with a leiomyoma.The surgical pathology report from that procedure noted corpus luteum cyst, superficial adenomyosis and leiomyoma of the myometrium and no lymphovascular space invasion was identified and no serosal involvement identified.In (b)(6) 2017, the patient was noted to have a firm and tender mass just to the left of the umbilicus which had been present for approximately two years.In (b)(6) 2018, the 6 x 6 cm periumbilical tumor involving all layers of the abdominal wall was removed along with a portion of the left rectus.Mesh was placed for abdominal wall reinforcement and to repair iatrogenic ventral hernia abdominal wall defect.Surgical pathology noted leiomyosarcoma, narrowly excised with a nearest peripheral margin of 0.3cm, grade 1 and the tumor size was noted to be 7.2 cm.The pathology specimen from this procedure as well as the pathology from the hysterectomy were reviewed and patologists were in agreement with the diagnosis of leiomyoma at the time of the hysterectomy in (b)(6) 2012 and the diagnosis of leiomyosarcoma at the time of the mass removal in (b)(6) 2018.The records provided reveal the patient is seeking second opinions at this time.No additional information received.

• Brand Name: GYNECARE MORCELLEX UNKNOWN PRODUCT
• Type of Device: LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7636046
• MDR Text Key: 112284135
• Report Number: 2210968-2018-73774
• Device Sequence Number: 1
• Product Code: HET
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1