ANDOVER, Mass. — Power morcellator manufacturer Smith & Nephew has been hit with an FDA warning for quality control failures at its Andover, MA plant.
The medical device manufacturing Smith & Nephew received a warning letter from the FDA for failing to meet quality control standards after multiple FDA inspections. The primary issue was the company’s “failure to establish and maintain procedures for verifying or validating corrective and preventative actions.” This stems from customer (i.e. surgeons) complaining there was a loss of visualization when using one of the company’s morcellators.
The product at risk here is the company’s Truclear Ultra Reciprocating Morcellator 4.0 – which is a disposable blade that is used with the brand’s Truclear Hysteroscope 8.0 While Smith & Nephew attempted to correct the issue and submit a report accordingly, they have been consistently receiving complaints. The first set of complaints from medical professionals came in 2012.
The FDA also found a lack of corrective behavior by Smith & Nephew for other surgical tools. This included having incorrect instructions for suture anchors; failing to test sterilization techniques on the Truclear Ultra Reciprocating Morcellators; and failing to document actions after complaints of the Beaver Blade product breaking during surgery.
Medical manufacturers are held to high standards because their products can have a life or death effect on patients. In this case, Smith & Nephew knew of problems with its various surgical blade products – issues that could have a tangible impact on patient safety and health. The company’s failure to conduct proper internal audits and find solutions is in violation of federal law. The FDA’s warning letter gives Smith & Nephew the chance to engage in adequate corrective measures. However, if the company does not take the necessary steps to bring its morcellator production line up to snuff, the agency will be forced to seize the devices, prevent the company from manufacturing and selling them, and instill monetary penalties.
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