If true, it?s a sad and grim tale. Citron Research released a highly unfavorable research report on Intuitive Surgical?s da Vinci robotic surgical system.
The Citron report, Has the Halo Been Broken on Intuitive Surgical ?, states that new analysis reveals the FDA received 4,600 reports of da Vinci robotic surgery complications: surgical burns, perforated and punctured organs, torn arteries and blood vessels, cut ureters, intestinal and bowel injuries, and death.
None of the adverse reports have seemed to dull Wall Street?s appetite for the pricey stock. The reason is simple: Intuitive Surgical’s full-year procedure count increased 28 percent, with procedure volume up 25 percent in the fourth quarter. Although daVinci-assisted prostatectomy procedures were down (down 17 percent in the U.S. for the fourth quarter), hysterectomy procedures increased 26 percent for the full year. Seeking Alpha estimates that Intuitive Surgical already has about 13-15 percent of the U.S. laparoscopic surgery market.
Quarterly sales rose 23 percent to $609 million while analysts had estimated $585 million. Procedures with the da Vinci surgical system, which allows for minimally invasive operations, increased 25 percent from a year earlier, fueled by greater use in gynecology and general surgery.
Trouble looms for the pioneering company
According to the Citron analysis, the most common da Vinci robotic surgery complications reported to the FDA include perforations (organ punctures), lacerations (cuts) and tears.
While many of these injures are allegedly attributed to doctor error, some cases are clearly describing machine malfunction, the report stated. The second-most prominent injury was electrocautery or burns from electrical discharge.
?There appear to be a variety of reasons when electricity is delivered at unintended times or to unintended tissues. One of the main sources is insulation flaws on the equipment,? Citron reported. In many of the worst alleged da Vinci Robot complications, the analysis found that the patient’s surgery was closed, reported successful, and they were discharged and sent home.
Only later did the patient take a turn for the worse. In such cases, the patient was readmitted to the hospital with internal bleeding, infection, and other serious injuries.
The Citron analysis also found instances where da Vinci robotic surgery complications were allegedly attributed to doctor error. According to the report, the training program for the da Vinci Robot takes only two days to complete.
However, Citron points out that there are published expert opinions that it takes hundreds of surgeries to become truly proficient on the da Vinci. There are also no established standards for judging proficiency on the machine, as each hospital has its own system to train surgeons and determine when they are proficient with the robot.
In a separate, earlier report dated December 19, 2012, Citron revealed that a total of nine da Vinci robotic surgery lawsuits have already been filed on behalf of alleged victims of da Vinci robotic surgery complications.
Plaintiffs allegedly required debilitating and painful subsequent surgeries to repair defects caused by the original robotic surgery, and aside from two patients who died, the remaining patients were left with severe long term adverse results, Citron said.Read More