MAUDE Adverse Event Report: ETHICON INC. GYNECARE MORCELLEX UNKNOWN PRODUCT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Iatrogenic Source (2498); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent to fda: 03/17/2017.(b)(4).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.It is unknown if the actual device used in this patient procedure was in fact an ethicon morcellator.The event investigation is ongoing.

Event Description

It was reported by an attorney that the patient underwent a laparoscopic-assisted vaginal hysterectomy with adhesiolysis on (b)(6) 2011 and a morcellator was utilized.It was reported that the undetected leiomyosarcoma metastasized and the patient died on an undisclosed date.No additional information was provided.

• Brand Name: GYNECARE MORCELLEX UNKNOWN PRODUCT
• 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: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6412799
• MDR Text Key: 241267439
• Report Number: 2210968-2017-31240
• Device Sequence Number: 1
• Product Code: OTN
• 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
• Type of Report: Initial
• Report Date: 02/22/2017

1 Device was Involved in the Event

2 Patient was Involved in the Event

• 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?: No
• Initial Date Manufacturer Received: 02/22/2017
• Initial Date FDA Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0
• Patient Outcome(s): Death; Other
• Patient Age: 48 YR