FDA Adverse Event Death Summary report: N

MORCELLATOR

MDR report key: 3835648 · Received May 21, 2014

Report

Report Number
MW5036255
Event Type
Death
Date Received
May 21, 2014
Date of Event
November 23, 2009
Report Date
May 20, 2014
Manufacturer
JOHNSON AND JOHNSON
Product Code
HET
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

MY WIFE (B)(6), SUBSEQUENT TO A HISTORY OF LONG TERM "UTERINE SYMPTOMS", TWO COURSES WITH IUD'S OF 6 AND 20 YEARS, POST MENOPAUSAL BLEEDING AND SPOTTING, AND A D AND C WITH ELECTRICAL ABLATION, PRESENTED TO HER GYNECOLOGIST IN (B)(6) 2009 WITH A CHIEF COMPLAINT OF ABDOMINAL SWELLING AND PRESSURE. IN ADDITION TO HER CLINICAL EVALUATION BY DR (B)(6) MD, (B)(6) ULTRASONIC AND MRI TESTING WAS ALSO ACCOMPLISHED. BASED ON (B)(6) MEDICAL HISTORY, HER CLINICAL PRESENTATION OF A RAPIDLY ENLARGING UTERUS AND HER TEST RESULTS, ON (B)(6) 2009, DR (B)(6) INFORMED MY WIFE THAT THE SWELLING IN HER UTERUS WAS "SUSPICIOUS FOR LEIOMYOSARCOMA." MY WIFE WAS REFERRED TO DR (B)(6), MD, (B)(6), A GYNECOLOGY CANCER SURGEON FOR CONSULTATION AND TREATMENT. MY WIFE WAS SEEN BY DR (B)(6) FOR EVALUATION AND PRE-SURGICAL CONSULTATION ON (B)(6) 2009 AT WHICH TIME I WAS PRESENT DURING THE WHOLE VISIT. AT NO TIME DURING THE VISIT DID DR (B)(6) DO A VERBAL REVIEW OF MEDICAL HISTORY WITH MY WIFE, AND HE APPEARED TO TAKE DR (B)(6) DIAGNOSIS LIGHTLY. HIS OPINION WAS THAT MY WIFE DIDN'T REALLY "FIT THE PROFILE" OF PATIENTS WITH UTERINE CANCER AND THAT THE POSSIBILITY OF CANCER WAS SMALL. HE RECOMMENDED A "VAGINAL HYSTERECTOMY" WITH MORCELLATION WHICH WOULD BE EASIER ON HER. DUE TO MY WIFE'S COMPLETE CONFIDENCE IN DR (B)(6) CONFIDENCE IN DR (B)(6), AN INFORMED CONSENT FOR SURGERY WAS DONE AND MY WIFE WAS SCHEDULED FOR SURGERY ON (B)(6) 2009 AT 6:00 PM. NEITHER THE VERBAL NOR THE WRITTEN INFORMED CONSENT THAT DAY MADE ANY MENTION OF THE POSSIBILITY OF THE SPREAD OF DISEASE IF ANY CANCER CELLS WERE PRESENT. ON (B)(6) 2009, I TOOK MY WIFE TO (B)(6) HOSPITAL, (B)(6) AT 4:30 PM TO BE PREPARED FOR SURGERY AT 6:00 PM. DR (B)(6) DID NOT ARRIVE UNTIL AFTER 8:00 PM AND THE SURGERY DID NOT START UNTIL AROUND 9:00 PM. WHILE WAITING IN THE PRE-OP AREA AFTER DR (B)(6) DID ARRIVE, MY WIFE AND I ASKED HIM TO NOT DO THE VAGINAL HYSTERECTOMY WITH MORCELLATION, AND TO INSTEAD DO A TRADITIONAL HYSTERECTOMY WITH AN ABDOMINAL ACCESS SO THE UTERUS COULD BE REMOVED INTACT. TO MAKE A LONG STORY SHORT, A VAGINAL APPROACH WAS DONE AND THE UTERUS WAS MORCELLATED. SUBSEQUENT TO THE SURGERY, MY WIFE HAD FOUR BOUTS OF INTESTINAL BLOCKAGE STARTING 11 DAYS AFTER THE OPERATION, NEW TUMOR AT THE OPERATIVE SITE WITHIN SIX WEEKS, SIX WEEKS OF ADDITIONAL TIME IN THE HOSPITAL, AND WAS BASICALLY INCAPACITATED FROM THE TIME OF SURGERY UNTIL HER DEATH 10 MONTHS LATER. SHE DIED FROM MASSIVE ABDOMINAL TUMEROSIS AND STARVATION. I BELIEVE NOT ONLY THAT THE MORCELLATOR WAS USED INDISCREETLY IN MY WIFE'S CASE, BUT ALSO THAT DR (B)(6) ASSAULTED MY WIFE WHEN HE PERFORMED A PROCEDURE THAT WE HAD WITHDRAWN CONSENT FOR. I HAVE COPIES OF ALL OF (B)(6) MEDICAL RECORDS PERTAINING TO THIS CASE INCLUDING THE PATHOLOGY REPORT AND SLIDES. RESPECTIVELY SUBMITTED, (B)(6), DDS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
302099 MORCELLATOR NONE HET JOHNSON AND JOHNSON

Patients

Seq Age Sex Outcome Treatment
1 64 YR Death| H| O| S