FDA Adverse Event Death Summary report: N

POWER MORCELLATOR INVOLVED IN MORCELLATION

MDR report key: 6348650 · Received February 20, 2017

Report

Report Number
MW5067976
Event Type
Death
Date Received
February 20, 2017
Date of Event
March 8, 2012
Report Date
February 20, 2017
Manufacturer
UNK
Product Code
HET
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
NC, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

DURING A HYSTERECTOMY, MY SISTER UNDERWENT A LAPAROSCOPIC REMOVAL OF HER UTERUS VIA MORCELLATION AS A MINIMALLY INVASIVE OPERATION. THE RESULTS OF THE LAB WORK SHOWED THE TISSUE TO BE CANCEROUS WHICH MEANT THOSE CELLS HAD BEEN "SCATTERED" THROUGHOUT HER ABDOMINAL CAVITY. THREE YEARS OF ADDITIONAL OPERATIONS, CHEMOTHERAPY, RADIATION, AND SUFFERING FOLLOWED AND ENDED WITH HER DEATH ON (B)(6) 2015.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
126469 POWER MORCELLATOR INVOLVED IN MORCELLATION LAPAROSCOPE GYNECOLOGIC HET UNK

Patients

Seq Age Sex Outcome Treatment
1 63 YR Death| H| L| S