It was reported that during laryngeal tumor surgery the procise coblator wand did not produce plasma and the controller was indicating that the wand was activated with audible tone.The procedure was successfully completed using a back-up device, there was not a significant delay.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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H10: h3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection of the returned instrument shows no manufacturing abnormalities.No visual issues were observed.The device was plugged into the controller and registered settings (7,3).The wand experienced intermittent plasma generation.A review of the customer provided images shows the packaging and confirms part number eic7070-01 and lot number 2043665.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was an isolated event.The complaint was confirmed and is associated with a component failure.Factors that could have contributed to the reported event include: a damaged wire causing a intermittent activation.No containment or corrective actions are recommended at this time.
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