The device, used in treatment, was returned for evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection under magnification shows the electrodes have been detached with jagged edges on the top remaining electrode legs and rounded edges on the bottom electrode leg.There is also discoloration on the adhesive and scuff marks on the spacer.There is a significant amount of scratch marks on the exposed shaft and black shrink tube near the tip and handle of the wand.The cable has been severed prior to being received for evaluation; therefore, a functional test could not be conducted.There are no manufacturing abnormalities visually observed with the returned device.The complaint has been visually verified and the root cause was more than likely associated with the device potentially coming into contact with a metal object such as a cannula.Other factors that could have led to tip detachment includes: mechanical displacement of tissue through applied force or using the device as a lever to enlarge a surgical site or gain access to tissue.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.
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