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

Catalog Number MX0100

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

Patient Problems Bleeding (1738); Pain (1994); Surgical procedure (2357); Iatrogenic Source (2498); Treatment with medication(s) (2571); Cancer (3262)

Event Date 05/25/2012

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent a robotic myomectomy due to dysfunction uterine bleeding, and a morcellator was used to remove fibroids and other uterine tissue.On (b)(6) 2013, the patient underwent a transvaginal sonogram, due to complaints of pelvic pain and dysfunctional uterine bleeding.The transvaginal sonogram revealed the presence of additional fibroids.On (b)(6) 2013, the patient underwent a supracervical laparoscopic hysterectomy and a morcellator was used for removal of the patient¿s uterus and parts of her cervix.On (b)(6) 2014, an ultrasound was performed due to the patient¿s complaints of continued pelvic pain.The ultrasound revealed two heterogeneous masses near the vaginal cuff.On (b)(6) 2014, the patient underwent a follow-up ct scan of the abdomen and pelvis which revealed multiple heterogeneously enhancing masses throughout the pelvis.On (b)(6) 2014, the patient underwent an exploratory laparotomy with resection and/or excision of multiple masses in the abdomen, pelvis and omentum.The ovaries and fallopian tubes were removed and an omentectomy was performed.The pathology report of the uterine tissue revealed a spindle-cell tumor of uncertain malignant potential (stump) and was noted to have infiltrated into the parametrial fiber dense tissue with high mitotic activity noted in the specimens.The patient continues to seek treatment at the cancer center with antagonistic hormonal therapy, including the administration of letrozole.The patient is required to undergo frequent radiological imaging, including periodic ct scans of the abdomen and pelvis to assess tumor recurrence and imaging of other parts of her body to screen for distant metastasis.

Manufacturer Narrative

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

Manufacturer Narrative

Date sent to the fda: 11/12/2015.Additional info.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Date sent to the fda: 3/1/2016.(b)(4) it was reported by an attorney that the patient underwent a surgical procedure on (b)(6) 2012 and a robotic myomectomy was performed to remove a fibroid.No additional information was provided.

• Brand Name: GYNECARE MORCELLEX TISSUE MORCELLATOR
• 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): DEFAULT ORGANIZATION; 4545 creek rd ml # 36; cincinnati OH 45242 2803
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4847086
• MDR Text Key: 5873991
• Report Number: 2210968-2015-07113
• 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,Followup,Followup
• Report Date: 05/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MX0100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2016
• 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 Age: 36 YR
• Patient Weight: 96