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Topic: Device
Publication Type: Patient Safety Alert
Single or Multiple Incident: Multiple
Date: 11/1/2009 12:00:00 AM
Country: Australia
Organization: Queensland Health (Australia)

"The Alert is related to the Valleylab Force FX Bipolar diathermy machine - supplied by Tyco Healthcare Pty Ltd. Valleylab provides, at the time of purchase, a Power Setting Advice Card which can be attached to the machine to advise recommended power levels for a particular procedure. The layout of the Three Diathermy Modes on the front panel of the machine appears from left to right: Bipolar Cut Coag The layout of the three Diathermy Modes on the card appears, from left to right: Cut Coag Bipolar. Additionally, the Power Advice Card represent Bipolar label in a White box, however on the machine panel, this box is Blue. The inconsistency in appearance increases the risk of error in translation of the information from the Power Setting Advice Card to the power-level panel on the front of the machine. At this time, TYCO has no plans to replace the cards. Specific Incidents A number of Clinical Incidents have been reported in relation to the above Bipolar Diathermy. A significant increase in post-polypectomy complications (including a bowel perforation) was found to be associated with the introduction of the Valleylab Force FX machine. Incident investigation suggested that the incidents arose due to erroneous setting of power levels on the machine. This was thought to have resulted from error in transfer of information obtained from the Instruction Guide to the power-level panel of the Diathermy unit."

Additional Details

Valleylab Force FX Bipolar Diathermy

Valleylab FORCE FX Bipolar Diathermy