Study Finds da Vinci Robotic Surgery Complications Underreported

Alleged Da Vinci robotic surgery complications have resulted in a growing number of injury reports and lawsuits nationwide. Now, a new study finds that problems with the revolutionary da Vinci robotic system may be underreported, asking the question: Despite numerous success stories and glowing reports from doctors, does the da Vinci robot carry more risks than are currently understood?

Researchers discover low number of complication reports

Researchers from Johns Hopkins University used an FDA database to identify da Vinci robotic surgery “adverse event” reports over a 12-year period. Each report was examined to determine whether it was inaccurate, filed late, or not filed at all. Reports were also cross-referenced with databases for LexisNexis and PACER, to determine the accuracy of the FDA reporting.

During the study period, 245 adverse events related to the robotic surgery system were reported to the FDA. These reports included 174 non-fatal injuries and 71 patient deaths. This appears on the surface to be a relatively low number of problems, in light of the fact that around one million surgeries were performed using the da Vinci device during the same time frame.

Late reporting, lack of reporting found in study

However, researchers also identified numerous events that were improperly reported to the FDA, or reported long after the incidents occurred. In some cases, the event was reported in mainstream media before arriving at the FDA. Time between the event and FDA reporting in some cases was more than 20 months.

Researchers also question whether some events are never getting reported to the FDA at all. In an anonymous survey of physicians who have used the da Vinci robot, more than half of those surveyed said they experienced operative malfunctions that required them to switch to laparoscopic or open surgery on a patient.

The lead researcher in the study, Martin Makary, told United Press International that he was concerned about the findings. Makary stated, “Doctors and patients can’t properly evaluate safety when we have a haphazard system of collecting data that is not independent and not transparent.”

Researchers also found that the robot surgery procedure most linked to complications was the daVinci hysterectomy. More than 43 percent of all problems reported were associated with hysterectomies, followed by urologic and cardiothoracic procedures. In some cases, patients required multiple subsequent procedures to repair the damage.

About da Vinci robotic surgery

The da Vinci surgical robot was approved by the FDA for use in the United States in 2000. The device was touted by its manufacturer as offering more precision and smaller incisions compared to traditional laparoscopic surgery. However, reports of serious complications and patient deaths have left some health professionals questioning the safety of the device. Alleged injuries have included perforated organs, surgical burns and torn blood vessels.

At least 33 injured patients have now filed a da Vinci surgical robot lawsuit against Intuitive.