SONOPLEX® STIM

Additional Manufacturer Narrative

THIS CASE IS REPORTED IN RETROSPECT BASED ON A RE-EVALUATION CONDUCTED IN 2025 FOR FORMAL REASONS. THERE WAS NO PARTICULAR RISK TO PATIENTS, USERS, OR THIRD PARTIES.

Description of Event or Problem

IRN# (B)(4). INCIDENT OCCURRED IN LITHUANIA. A SUPRACLAVICULAR BLOCK OF THE BRACHIAL PLEXUS WAS PERFORMED UNDER ULTRASOUND GUIDANCE TO ANESTHETIZE THE PATIENT. AFTER SUCCESSFULLY VISUALIZING THE PLEXUS AND EXTRACTING POTENTIALLY DEFECTIVE REGIONAL ANESTHESIA NEEDLE WITH THE LOCAL ANESTHETIC MIXTURE, THE LATTER DISLODGED FROM THE PLASTIC HUB RETAINER AND REMAINED UNDER THE SKIN. THE INTERVENTION SITE WAS EXAMINED BY ULTRASOUND REVEALING A SOLID NEEDLE STILL PRESENT IN THE SUBCUTANEOUS TISSUE, BUT THE TIP OF THE NEEDLE COULDN'T BE REACHED FROM THE OUTSIDE. THE PLASTIC SURGEON ON DUTY WAS URGENTLY INFORMED AND ARRIVED PROMPTLY. UNDER LIDOCAINE-ANESTHETIZED ULTRASOUND GUIDANCE, THE SHOULDER AREA TISSUES WERE SEPARATED AND THE FOREIGN BODY (NEEDLE) REMOVED. AFTER REMOVAL IT WAS CONFIRMED THAT THE NEEDLE WAS SOLID, AND ULTRASOUND FURTHER CONFIRMED THAT NO PARTS OF THE NEEDLE REMAINED IN THE TISSUES.