MAUDE Adverse Event Report: ETHICON INC. GYNECARE MORCELLEX UNKNOWN PRODUCT; LAPARSCOPE, GYNECOLOGIC

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Surgical procedure (2357); Iatrogenic Source (2498); Treatment with medication(s) (2571)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent a total laparoscopic hysterectomy for the removal of uterine fibroids on (b)(6) 2011 and a tissue morcellator was utilized for tissue removal during the surgery.Prior to the surgery, the patient underwent testing, which showed no evidence of cancer.During the surgery a biopsy was taken, which revealed endometrial stromal sarcoma/leiomyosarcoma.The patient was treated and believed to be free of the disease, until (b)(6) 2013 the patient was diagnosed with a recurrence of leiomyosarcoma.The patient underwent an exploratory laparotomy and debulking of a pelvic/abdominal wall mass on (b)(6) 2013, which confirmed metastatic endometrial sarcoma, involving the pelvis and left anterior abdominal wall through the peritoneum.No additional information was provided at this time.

Manufacturer Narrative

(b)(4).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.

Manufacturer Narrative

(b)(4).

• Brand Name: GYNECARE MORCELLEX UNKNOWN PRODUCT
• Type of Device: LAPARSCOPE, GYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): MEDTECH GROUP INC; 6 century ln; south plainfield NJ 07080
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4699063
• MDR Text Key: 5726541
• Report Number: 2210968-2015-04572
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 65