• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC. MYOSURE; HYSTEROSCOPE (AND ACCESSORIES)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HOLOGIC, INC. MYOSURE; HYSTEROSCOPE (AND ACCESSORIES) Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Death (1802); Dyspnea (1816); Edema (1820); Fluid Discharge (2686); Cancer (3262)
Event Date 11/13/2015
Event Type  Death  
Event Description
Hello, (b)(6) 2020 my name is (b)(6).My mom, (b)(6), died from a uterine cancer in (b)(6) of 2015.She had a "hysteroscopy and fractional d&c" on (b)(6) 2015 in (b)(6) because a prior pap smear and a prior ultrasound both showed areas of her uterus to be "suspicious for malignancy".The "impression" from page 2 of 2 of her "history and physical" shows "post-menopausal bleeding with suspicion for endometrial cancer." this statement was dictated and transcribed on (b)(6) 2015 at 1500 hrs, one day before this procedure.This operation was performed with a myosure morcellator built by hologic.This procedure confirmed the suspected and expected carcinosarcoma.I found this out after reading through her medical records which i had asked for, because she has several granddaughters that i felt might possibly benefit from this information.Then on (b)(6) 2015 she underwent a second surgery for a hysterectomy and lymphadenectomy in (b)(6).However, by this time, half of the excised lymph nodes were metastatic.All of this information is in her medical records (which also mention mullerian tumor and leiomyoma).After this 2nd procedure the dr.Told her that she would most likely die in a few months even if she agreed to conventional treatment (chemotherapy) for this very aggressive disease.Bravely and courageously, she chose to live her remaining time without treatment and then did great until (b)(6) 2015 when she was admitted to the hospital in (b)(6).She was in the (b)(6) hospital for a couple of weeks, then transferred to (b)(6) for about a week.After this, hospice set up a place for her at my sister's house in (b)(6) for a brief time and all of her kids and family were able to be with her for this last week or so before she passed.During this time she was completely incapacitated with swollen limbs and unable to move around so that my sisters especially had to turn her, bath her and assist her as they could while she was bedridden the whole time.Her legs swelled to the point that her skin was tight and it split, and it wept fluid to the point that it was just about impossible to keep her dry and comfortable.The last couple of days of her life were spent listening to her drown to death as her lungs filled with fluid and her breathing became increasingly difficult and shallow until at the end there was simply no more room in her lungs for air exchange.Other than her terrifying diagnosis her last summer, she was otherwise in good health, and she was able to spend time fishing and huckleberrying with my dad (2015).Hospice provided meds for her last couple of weeks, which we are thankful for, but this time was a nightmare for the entire family, knowing the grim outcome we faced.Her loss caused my dad extreme grief and we almost lost him also, over the coming months.I feel that it is unfortunate that she developed this cancer at all, but it is particularly painful to think that the initial "treatment" (robotic d&c using a myosure / hologic morcellator) which she underwent spread a particularly deadly malignancy throughout her system.Inexplicably, this procedure was performed after and despite the april, 2014 nationwide fda safety warnings about the risks power morcellation poses for spreading undetected cancers throughout and beyond the uterus.The agency stated "if laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient's likelihood of long term survival.For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have uterine sarcoma, the fda discourages the use of laparoscopic power morcellation during hysterectomy and myomectomy." in other words, the fda specifically recommends that surgeons perform these procedures using alternate, less risky, and safer methods.My mom's death certificate says that her cause of death was uterine cancer.Now you know the circumstances that contributed to this tragedy and her premature death.This surgery was performed in (b)(6).When the myosure equipment is used for this surgery, a saline solution is used by the surgeon and it is pumped into the uterus through a port in the myosure, to clear the scope and to keep the uterus "inflated" while the surgeon works, so that he/she can observe the procedure and effectively guide the rotating cutter to, and through, the targeted tissue.This tissue is usually composed of fibroids, but if a patient has a carcinosarcoma present then these cells are dispersed into the uterus and into the saline solution.Because this solution is under pressure, it then effectively metastasizes this cancer throughout the patient's body.This possibility is clearly demonstrated by the fact that a consequence of extended exposure to the saline solution present during the procedure is a dangerous homeostatic imbalance due to the uptake of the saline solution into the bloodstream.While the saline solution is necessary to the procedure, it also provides a current or vehicle into the patient's bloodstream and then to other organs and tissues.This procedure was recommended and carried out even though the medical record includes the chilling statements, "suspicious for malignancy" and "suspicion for endometrial cancer." either of these observations should have been amply sufficient to ensure that this procedure, using this technique, never, ever happened.Inexplicably, this procedure was performed after and despite the fact that hologic specifically warns against using their myosure equipment on this segment of the population, given the diagnosis my mom had (suspicion for malignancy, suspicion for endometrial cancer).Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MYOSURE
Type of Device
HYSTEROSCOPE (AND ACCESSORIES)
Manufacturer (Section D)
HOLOGIC, INC.
MDR Report Key10559672
MDR Text Key207902270
Report NumberMW5096749
Device Sequence Number1
Product Code HIH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 09/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age71 YR
Patient Weight88
-
-