Continued Use of "Flying Lead" Bipolar Electrosurgical Cables Could Result in Misconnections and Patient Burns

November 28, 2018 | Evaluations & Guidance


"Flying lead" bipolar electrosurgical cables can be inappropriately connected to the monopolar electrode jacks on general-purpose electrosurgical units (ESUs). Such misconnections can lead to inadvertent ESU activation and unintentional patient burns or other injury (e.g., bowel perforation).

Flying lead cables are bifurcated at the plug end with two separate connectors. Each connector is intended to be inserted into one of the two bipolar electrode jacks on the ESU. However, the physical separation of these connectors (because they have flying leads) allows them to be inappropriately inserted into the wrong electrode jacks on the ESU (see the figure).

When a bipolar electrode is wrongly connected to the monopolar jacks on an ESU, the generator may, under certain circumstances, activate without intervention from the surgeon. Inadvertent activation is possible if, while the patient is in contact with a monopolar return electrode that is...

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