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Hysteroscopic morcellation: review of the manufacturer and user facility device experience (MAUDE) database
Karina Haber1, Eleanor Hawkins1, Mark Levie1
1Department of Obstetrics and Gynecology, Danbury Hospital, Danbury, Connecticut; Department of Minimally Invasive Gynecological Surgery, Montefiore Medical Center, Bronx, New York.
Study Objective:
To investigate the number and type of adverse events associated with hysteroscopic morcellation of intrauterine disease.
Design:
Systematic review of Manufacturer and User Device Experience (MAUDE) database from 2005 to June 2014 (Canadian Task Force classification III).
Setting N/A Patients:
Women undergoing hysteroscopic surgery for removal of intrauterine polyps or myomas with use of a reciprocating morcellator.
Interventions:
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.
Measurements And Main 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.
Insights
Hysteroscopic morcellation for intrauterine conditions is associated with adverse events in less than 0.1% of cases. While complications like uterine perforation and fluid overload can occur, they are less frequent than with traditional methods.
Area of Science:
- Gynecologic Surgery
- Minimally Invasive Procedures
- Patient Safety
Background:
- Hysteroscopic morcellation is utilized for removing intrauterine polyps and myomas.
- Traditional resectoscopy carries risks of adverse events.
- Newer morcellation devices aim to improve safety profiles.
Purpose of the Study:
- To determine the incidence and types of adverse events linked to hysteroscopic morcellation.
- To assess the safety of hysteroscopic morcellation devices.
Main Methods:
- Systematic review of the Manufacturer and User Device Experience (MAUDE) database (2005-2014).
- Analysis of 119 reported adverse events, categorized by severity and manufacturer.
- Utilized device sales data as a surrogate for procedure volume.
Main Results:
- 119 adverse events were reported, including major complications (e.g., bowel damage, hysterectomy) and minor issues (e.g., uterine perforation, device failure).
- Adverse events complicated hysteroscopic morcellation in less than 0.1% of estimated procedures.
- Specific morcellation devices were analyzed for reported complications.
Conclusions:
- Hysteroscopic morcellation, despite potential adverse events, appears safer than traditional electrocautery.
- Life-threatening complications are infrequent but documented.
- The MAUDE database provides valuable insights into device safety, though limitations exist.
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