MAUDE Adverse Event Report: ETHICON A DIVSION OF JOHNSON & JOHNSON MORCELLATOR

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Cancer (3262)

Event Date 09/26/2012

Event Type  Death  

Event Description

I write to provide info about a case involving a cancer diagnosis after robot-assisted supracervical laparoscopic hysterectomy with the use of a morcellator in (b)(6) 2012.The female pt is bl, date of birth (b)(6) 1970.The surgery was performed at (b)(6) hospital on (b)(6) 2012.The tp's pathology diagnosis after the surgery included leiomyosarcoma.The pt developed metastatic sarcoma in the sigmoid mesentery, and died of her disease on (b)(6) 2014.The morcellator used in the (b)(6) 2012 surgery was manufactured by ethicon a division of johnson & johnson.The pt's family has brought a lawsuit against the mfr of the morcellator, so the mfr is on notice of this issue.The pt's experience has received attention in the media, along with the experience of two other pts in the (b)(6) area.Neither of those other two pts had the subject surgery at (b)(6) hospital.Please let me know if you have questions about this pt's experience at strong memorial hospital.

• Brand Name: MORCELLATOR
• Type of Device: MORCELLATOR
• Manufacturer (Section D): ETHICON A DIVSION OF JOHNSON & JOHNSON
• MDR Report Key: 5314464
• MDR Text Key: 34112836
• Report Number: MW5058620
• Device Sequence Number: 1
• Product Code: HET
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2015
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 42 YR