Silex Medical, LLC is recalling approximately 169 Signature Laparoscopic Instruments because the insulation on the instrument's shaft does not extend fully, leaving a section of the metal exposed near the handle's rotator wheel. This defect can allow electricity to escape to unintended areas of the body during surgery, which may cause internal or external burns. There have been no reports of injuries or incidents to date. The affected tools were distributed to hospitals and surgical centers across 15 states.
The exposed metal on the device shaft can conduct electrosurgical energy to patients or surgical staff in areas not intended for treatment. This creates a significant risk of unintended electrical burns during laparoscopic procedures.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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