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FDA issues Class I recall over Medtronic brain surgery software

FDA issues Class I recall over Medtronic brain surgery software

The Class I recall, the most serious type of recall, was issued for four separate versions of Medtronic’s StealthStation S8 application. Credit: Shutterstock

FDA issues Class I recall over Medtronic brain surgery software

 

The Class I recall was issued after users complained that the Medtronic software displays text that incorrectly leads neurosurgeons to misleading instruction

The US Food and Drug Administration (FDA) has issued a Class I recall for a piece of medtronic software used in locating anatomical structures during brain surgeries after it was found to display faulty text that potentially misleads surgeons.

The Class I recall, the most serious type of recall, was issued for four separate versions of Medtronic’s StealthStation S8 application, designed to be used with a surgical drill, after customer complaints about a software error causing numbers or letters to be missing from the displayed text and replaced by a space. This could cause the surgeon to use an incorrect measurement for placement of the biopsy tip stop during navigation in neurosurgery.

The FDA states  that performing a cranial procedure using incorrect placement could lead to serious permanent injuries, including brain, nerve, or cerebrovascular damage, abnormal functions to the brain, spine, or muscles, paralysis, or death.

Medtronic added that they have  received 28 reports related to the issue with no injuries or deaths caused because of the error. The company has now issued an Urgent Medical Device Correction letter, stating that they are working on a free update to the software designed to address the specific issue. The affected software versions are versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1.

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Medtronic Brain Surgery Software Recall: A Breakdown

The FDA’s Class I recall of Medtronic’s brain surgery software wasn’t caused by a faulty image, but by a critical issue with how the software displayed text. Let’s delve deeper into this situation.

The Glitch:

Medtronic’s StealthStation S8 is a software program used during brain surgery to help surgeons navigate and locate anatomical structures precisely. Unfortunately, certain versions of this software were found to have a glitch. This glitch caused crucial information, like numbers or letters, to be replaced by blank spaces within the displayed text.

The Risk:

The missing characters were particularly concerning for measurements displayed during surgery. For instance, the distance to a target area within the brain might be shown as “Distance to Target: 8_.5 mm” instead of the correct value. Misinterpreting such measurements due to the missing information could lead surgeons to make inaccurate placements of surgical tools, potentially causing serious harm to the patient.

The Recall:

The FDA, recognizing the potential for severe consequences, issued a Class I recall. This is the most serious type of recall, reserved for situations where there’s a reasonable likelihood of causing serious injury or death. The recall specifically targeted four versions of the StealthStation S8 application.

Timeline of Events:

  • Around April 2023: Medtronic became aware of the software glitch and proactively reached out to healthcare providers, informing them about the problem and assuring them that a software update was forthcoming.
  • By September 2023: The FDA received complaints from users about the software malfunction and proceeded to issue the Class I recall. Thankfully, Medtronic reported no injuries or deaths associated with the glitch at that time.

Current Status and Recommendations:

Medtronic has likely released a software update to rectify the glitch. Surgeons and healthcare facilities are advised to strictly follow instructions from both Medtronic and the FDA regarding the affected software versions. This may involve not using those specific versions or implementing specific workarounds until the updated software is installed.

 

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