CASE STUDY #3

ESU Electrodes Not Fully Seated

Baretich Engineering has investigated several cases in which patients experienced ESU (electrosurgical unit) burns remote from the surgical site. In two cases, ESU electrodes were found to have been not fully seated in the ESU handpiece.

When an ESU electrode is fully seated, the high-voltage, high-frequency current generated by the ESU can flow only through the distal tip of the electrode. This is because the electrical conductor is insulated along its entire length. When the electrode is fully inserted into the handpiece (first photo, blue electrode), it fits into an insulating socket.

When an ESU electrode is only partially inserted (second photo, blue electrode), the proximal end of the electrode is uninsulated because it is not within the insulating socket of the handpiece. This creates and uninsulated gap (third photo) that allows ESU current to flow to tissue remote from the surgical site and can cause burns to the patient.

Due to the internal configuration of the handpiece, an electrode being inserted will encounter physical resistance when it is inserted about halfway. In this position (first photo) the electrode may appear to be fully inserted because the entire visible length is insulated (blue material). For full seating, the electrode must be pushed more firmly and farther into the handpiece.

We recommended that the organizations make the clinical staff aware of this issue while reviewing alternative sources for the handpiece. We also recommended reporting the incidents to FDA and to ECRI Institute to enable wider communication of this issue.