title: Hysteroscopic morcellation: review of the manufacturer and user facility device experience (MAUDE) database.
abstract: OBJECTIVE
  To investigate the number and type of adverse events associated with hysteroscopic morcellation of intrauterine disease.
  
  
  METHODS
  Systematic review of Manufacturer and User Device Experience (MAUDE) database from 2005 to June 2014 (Canadian Task Force classification III).
  Women undergoing hysteroscopic surgery for removal of intrauterine polyps or myomas with use of a reciprocating morcellator.
  
  
  METHODS
  The MAUDE database was searched for the key words "Hysteroscope," "Hysteroscopic reciprocating morcellator," "Interlace," "MyoSure," "Smith & Nephew," and "TRUCLEAR," to identify reported incidences of device malfunction, injury, or death. A total of 119 adverse events were analyzed. Reports were reviewed individually and categorized by date of occurrence, type of morcellation device, type of complication, and a brief description. Each company was contacted to provide an estimate of the number of procedures performed or units sold to date.
  
  
  RESULTS
  From 2005 to June 2014, 119 adverse events were reported to the MAUDE database. On the basis of severity, adverse events were categorized as major or minor complications. Major events included intubation/admission to an intensive care unit (n = 14), bowel damage (n = 12), hysterectomy (n = 6), and death (n = 2). Minor events included uterine perforation requiring no other treatment (n = 29), device failure (n = 25), uncomplicated fluid overload (n = 19), postoperative bleeding controlled using noninvasive measures (n = 6), and pelvic infection (n = 4). These events were then categorized according to manufacturer. The number of adverse events reported to the MAUDE database was divided by the total units sold as a surrogate for the estimated number of procedures performed. Understanding the limitation of the numbers used as a numerator and denominator, we concluded that adverse events complicated hysteroscopic morcellation in <0.1% cases.
  
  
  CONCLUSIONS
  The suction-based, mechanical energy, rotating tubular cutting system was developed to overcome adverse events that occur during traditional resectoscopy. On the basis of acknowledged limited information from the MAUDE database, it seems that life-threatening complications such as fluid overload, uterine perforation, and bleeding do occur with hysteroscopic morcellation but less frequently than with traditional electrocautery.
authors.affiliation: Department of Obstetrics and Gynecology, Danbury Hospital, Danbury, Connecticut; Department of Minimally Invasive Gynecological Surgery, Montefiore Medical Center, Bronx, New York. Electronic address: karinahaber@gmail.com.
authors.forename: Karina
authors.initials: K
authors.lastname: Haber
authors.affiliation: Department of Obstetrics and Gynecology, Danbury Hospital, Danbury, Connecticut; Department of Minimally Invasive Gynecological Surgery, Montefiore Medical Center, Bronx, New York.
authors.forename: Eleanor
authors.initials: E
authors.lastname: Hawkins
authors.affiliation: Department of Obstetrics and Gynecology, Danbury Hospital, Danbury, Connecticut; Department of Minimally Invasive Gynecological Surgery, Montefiore Medical Center, Bronx, New York.
authors.forename: Mark
authors.initials: M
authors.lastname: Levie
authors.affiliation: Department of Obstetrics and Gynecology, Danbury Hospital, Danbury, Connecticut; Department of Minimally Invasive Gynecological Surgery, Montefiore Medical Center, Bronx, New York.
authors.forename: Scott
authors.initials: S
authors.lastname: Chudnoff
mesh_terms: D016208:Databases, Factual; D004564:Electrocoagulation; D005260:Female; D006801:Humans; D015907:Hysteroscopy / Q000009:adverse effects* / Q000295:instrumentation; D007422:Intestines / Q000293:injuries*; D007889:Leiomyoma / Q000601:surgery*; D011127:Polyps / Q000601:surgery*; D014481:United States; D014486:United States Food and Drug Administration; D014592:Uterine Hemorrhage / Q000209:etiology*; D063186:Uterine Myomectomy / Q000009:adverse effects; D014594:Uterine Neoplasms / Q000601:surgery*; D014595:Uterine Perforation / Q000209:etiology*
keywords: Hysteroscope; Interlace; MyoSure; Smith & Nephew; TRUCLEAR; hysteroscopic reciprocating morcellator