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Senhance Surgical System Recalled by Manufacturer Because of Malfunction

surgery-3034133_640-e1709790370516Recently, Asensus Senhance Surgical System recalled its Senhance Surgical System in a Class I recall. The Class I recalls are the most serious recalls because they indicate that using the recalled device could result in death or serious injuries. The systems were distributed between April 13, 2023 – September 7, 2023. If you were injured as a result of a malfunctioning Senhance Surgical System, you should call the seasoned product liability lawyers of Moll Law Group. Billions have been recovered in product liability litigation with which we’ve been involved.

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You may be affected by the recall of the Senhance Surgical System if you’re going through or have gone through general laparoscopic surgical procedures or laparoscopic gynecological surgeries. Medical professionals use the Senhance Surgical System, which is a robotic surgery device, to help with laparoscopic surgeries.

The Senhance Surgical System is meant to be used by trained doctors when performing general laparoscopic surgical procedures and laparoscopic gynecological surgeries. The manufacturer expects this medical device to be used exclusively in an operating room environment, with reference to the instructions for use. Those who are two-year-old and older with a weight of at least 10kg and who can undergo conventional endoscopic techniques can be administered care through this device. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.

Unfortunately, it’s been found that the system has malfunctions. Patients have not been injured or harmed, or haven’t reported injuries or harms, but it’s important not to use the recalled machine because critical tissue trauma could occur with use. In those malfunctions the robotically assisted surgical device has uncontrolled arm motion of its Laparoscopic Instrument Actuator (LIA); the LIA rotated in a single directed after a surgeon took away the teleoperation capability. The system does have emergency stop capabilities.

The manufacturer sent an Urgent Medical Device Recall letter to all consumers that were impacted. The consumers, typically medical practices or hospitals, were told to stop using the team until the manufacturer’s service team had updated the device’s software and asked to sign an acknowledgement or receipt and send it back to the company.

Sometimes defective or malfunctioning medical devices cause serious injuries to patients. If your doctor used the Senhance surgical system, and you believe that it may have caused your injuries, it’s important to seek legal representation and determine whether you have any recourse. Sometimes these cases involve both medical malpractice and product liability issues. When we are able to establish liability, we can recover compensatory damages on your behalf. These are monetary awards intended to put you back in the position you would have been in had there been no use of the defective device such as medical expenses, lost wages, pain and suffering, replacement services, and out-of-pocket costs.

If you or a loved one were harmed by the recalled Senhance surgical system, you should call the seasoned Chicago-based product liability lawyers of Moll Law Group to discuss your legal options. We represent injured plaintiffs and grieving families across the country. Please complete our online form or call us at 312.462.1700.

 

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