(b)(4).The incident ultrasonic dissector was returned for evaluation.Visual inspection of the disposable hand piece revealed that the device had been used and the static part of the jaw had broken off.The broken piece was not returned with the rest of device.The remaining waveguide was inspected under magnification to identify the point of initial contact and fracture.It was concluded that the titanium waveguide fractured during use and eventually broke off.The titanium waveguide may have come in contact with a hard metallic object such as hemostat or retractor as evidenced by the break point and metallic scraping.The user¿s guide for this system warns: contact between the active blade and other metal objects (hemostats, clips, staples, retractors, etc.) may result in unintended damage to tissue and/or device failure.
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