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Defective medical device came with inadequate instructions

Nearly everyone who has spent any time in a hospital probably has a pretty good idea that cleanliness is of the utmost importance. Some visitors might even be hard-pressed to travel more than a few feet in a California hospital without encountering a hand-sanitizing station. However, in situations where a sterile environment is required, it is possible that a defective medical device may not have been getting the job done.

A defective product is not always one that malfunctions, but may simply be dangerous due to a manufacturer's lack of instructions or warnings. This is apparently what happened with a surgical tool manufactured by Greatbatch Medical Orthopedic. The initial instructions that accompanied the tool required that it be sterilized by steam. A later review found that this was inadequate.

The use of an improperly sterilized tool during surgery can present serious risk to the patient. According to the Food and Drug Administration, this non-sterile tool doesn't just pose the risk of injury, it can cause death as well. The FDA apparently did not elaborate on that claim, but the risk of injury and death presumably comes from possible infections from non-sterile tools or objects used in a surgical theater. 

Greatbatch Medical Orthopedic voluntarily issued a recall over its defective medical device, and it will likely revise the tool's instructions to include the correct procedure for sterilizing it. In the meantime, it's possible that patients in California have been victim to this or similar reusable surgical tools that were defective because of a problem in manufacturing or a lack of proper instructions. Injuries such as this are often compensated through a successfully navigated products liability claim rather than a medical malpractice case.

Source:, "7 Recent Medical Device Failures Catching FDA's Eye", Chris Newmarker, Dec. 5, 2014

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