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Related Experiment Videos

Complications associated with optical-access laparoscopic trocars.

Howard T Sharp1, Mark K Dodson, Michael L Draper

  • 1Department of Obstetrics and Gynecology, University of Utah School of Medicine, Salt Lake City, Utah, USA. howard.sharp@hsc.utah.edu

Obstetrics and Gynecology
|June 1, 2002
PubMed
Summary

Serious complications from optical-access trocars are underreported in medical literature. Post-market surveillance reveals numerous injuries, including major vascular damage and bowel perforations, indicating a need for greater awareness.

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Area of Science:

  • Surgical safety
  • Medical device surveillance
  • Laparoscopic surgery

Background:

  • Optical-access trocars were introduced in 1994 to enhance safety during laparoscopic procedures by enabling visualization of abdominal wall layers.
  • Few complications associated with optical-access trocars have been documented in peer-reviewed medical literature.

Purpose of the Study:

  • To investigate serious complications linked to optical-access trocars.
  • To analyze data from sources beyond traditional medical literature.

Main Methods:

  • Searched MEDLINE, FDA's Medical Device Reporting (MDR), and Manufacturer and User Facility Device Experience (MAUDE) databases.
  • Identified and categorized complications reported for optical-access trocars since their introduction.

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Main Results:

  • Only two serious complications were found in the medical literature.
  • The MDR and MAUDE databases reported 79 serious complications, including 37 major vascular injuries, 18 bowel perforations, and 20 cases of significant bleeding.
  • Four of these reported complications resulted in patient fatalities.

Conclusions:

  • Optical-access trocars are associated with significant injuries, despite their design for visualization.
  • Post-market data suggests a higher complication rate than previously reported in medical literature.
  • Increased vigilance and reporting are necessary to fully understand the risks.