FDA Adverse Event Injury Summary report: N

GYNECARE X-TRACT TISSUE MORCELLATOR

MDR report key: 3852019 · Received June 5, 2014

Report

Report Number: 2210968-2014-07193
Event Type: Injury
Date Received: June 5, 2014
Date of Event: January 15, 2010
Report Date: May 21, 2014
Manufacturer: ETHICON INC.
Product Code: HET
PMA / PMN Number: K993801
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4) - LEIOMYOMA SARCOMA OCCURRED. 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.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC MYOMECTOMY WITH UTERINE MORCELLATION ON (B)(6) 2010. A PREOPERATIVE EXAMINATION WAS PERFORMED WITH MRI AND THE TARGET MYOMA SHRANK WITH GONADOTROPIN-RELEASING HORMONE FROM 8 TO 6CM. THE DOCTOR JUDGED THIS TO BE LOW RISK. A POST OPERATIVE PATHOLOGICAL EXAMINATION REVEALED THE REMOVED TISSUE TO BE A LEIOMYOMA. DURING A REOPERATION, THE DOCTOR CONFIRMED A WIDELY DISSEMINATED MALIGNANCY INTO THE PERITONEAL CAVITY. THE PATIENT HAS SINCE EXPIRED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
329130	GYNECARE X-TRACT TISSUE MORCELLATOR	LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)	HET	ETHICON INC.	UNK	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	44 YR		Death\| L