title: Complications of Electromechanical Morcellation Reported in the Manufacturer and User Facility Device Experience (MAUDE) Database.
abstract: OBJECTIVE
  To evaluate adverse events associated with electromechanical morcellation as reported to the Manufacturer and User Facility Device Experience (MAUDE) database.
  
  
  METHODS
  Retrospective analysis of an established database (Canadian Task Force classification III).
  
  
  METHODS
  A search of the MAUDE database for terms associated with commercially available electromechanical morcellation devices was undertaken for events leading to injury or death between 2004 and 2014. Data, including the types of injury, need for conversion to open surgery, type of open surgery, and clinical outcomes, were extracted from the records.
  
  
  RESULTS
  Over a 10-year period, 9 events associated with death and 215 events associated with patient injury or significant delay of the surgical procedure were recorded. These involved 137 device failures, 51 organ injuries, and the morcellation of 27 previously undiagnosed malignancies. Of the 9 deaths, 1 was associated with organ injury, and the other 8 were associated with morcellation of cancer. Of the 27 undiagnosed cancers, 5 were reported by the manufacturer, 8 were reported by the patient or family, 9 were reported by medical or news reports, 2 were reported by medical professionals, and 3 were due to litigation. Morcellation of an undiagnosed malignancy was first reported to the database in December 2013.
  
  
  CONCLUSIONS
  The MAUDE database appears to detect perioperative events, such as device failures and organ injury at the time of surgery, but appears to be poor at detecting late events after surgery, such as the potential spread of cancer. Outcome registries are likely a more efficient means of tracking potential long-term adverse events associated with surgical devices.
authors.affiliation: Division of Gynecologic Oncology, Levine Cancer Institute, Carolinas Medical Center, Charlotte, NC. Electronic address: wnaumann@mac.com.
authors.forename: R Wendel
authors.initials: RW
authors.lastname: Naumann
authors.affiliation: The University of Texas M.D. Anderson Cancer Center, Houston, TX.
authors.forename: Jubilee
authors.initials: J
authors.lastname: Brown
mesh_terms: D016208:Databases, Factual; D004564:Electrocoagulation / Q000009:adverse effects* / Q000706:statistics & numerical data; D004867:Equipment Design; D004868:Equipment Failure / Q000706:statistics & numerical data*; D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D000069577:Morcellation / Q000009:adverse effects* / Q000295:instrumentation*; D012189:Retrospective Studies; D016896:Treatment Outcome
keywords: MAUDE database; Morcellation