MAUDE Adverse Event Report: MYOSURE POWER MORCELLATOR; HYSTEROSCOPE (AND ACCESSORIES)

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Death (1802); No Code Available (3191); Cancer (3262)

Event Date 11/01/2013

Event Type  Death  

Event Description

My wife's physician failed to properly use the myosure power morcellator during surgery.She alternated using the device and other instruments to remove cancerous tissue through my wife's vagina.Thus not using the myosure containment device for tissue removal.For the next 6 years my wife had numerous surgeries for the removal of metastatic cancer.My wife also was not given options as to the type of surgery or the use of the myosure device.Fda safety report id# (b)(4).

• Brand Name: MYOSURE POWER MORCELLATOR
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• MDR Report Key: 10395924
• MDR Text Key: 202719598
• Report Number: MW5096005
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Other; Disability
• Patient Age: 60 YR