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Complications of Electromechanical Morcellation Reported in the Manufacturer and User Facility Device Experience
R Wendel Naumann1, Jubilee Brown2
1Division of Gynecologic Oncology, Levine Cancer Institute, Carolinas Medical Center, Charlotte, NC.
Study Objective:
To evaluate adverse events associated with electromechanical morcellation as reported to the Manufacturer and User Facility Device Experience (MAUDE) database.
Design:
Retrospective analysis of an established database (Canadian Task Force classification III).
Intervention:
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.
Measurements And Main 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.
Insights
The Manufacturer and User Facility Device Experience (MAUDE) database captured 224 adverse events, including 9 deaths, related to electromechanical morcellation between 2004-2014. This system struggles to track late-stage complications like cancer spread.
Area of Science:
- Medical Device Safety
- Surgical Technology
- Adverse Event Reporting
Background:
- Electromechanical morcellation is used in minimally invasive surgery.
- Adverse events associated with surgical devices require robust monitoring.
- The Manufacturer and User Facility Device Experience (MAUDE) database collects device-related adverse event information.
Purpose of the Study:
- To evaluate adverse events linked to electromechanical morcellation devices.
- To assess the utility of the MAUDE database in capturing these events.
Main Methods:
- Retrospective analysis of the MAUDE database from 2004 to 2014.
- Searched for terms related to electromechanical morcellation devices.
- Extracted data on injuries, conversions to open surgery, and clinical outcomes.
Main Results:
- Over 10 years, 224 events were recorded, including 9 deaths and 215 injuries or delays.
- Events involved 137 device failures, 51 organ injuries, and 27 undiagnosed malignancies.
- 8 deaths were linked to cancer morcellation; 27 undiagnosed cancers were identified.
Conclusions:
- The MAUDE database effectively captures perioperative events like device failures and organ injuries.
- The database is less effective at detecting late adverse events, such as cancer dissemination.
- Outcome registries may be superior for tracking long-term adverse events from surgical devices.
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