The fiberoptic retractor subject of the reported event was returned for evaluation.Evaluation of the device determined that the root cause is due to user facility personnel using the incorrect cable size with the fiberoptic retractor.User facility personnel were utilizing a 5mm size instead of a 3.5mm.The instructions for use states, "1) these devices must only be used with a 3.5mm size fiber optic bundle cable.Do not use this device with a larger size cable.Failure to use the correctly sized cable will cause the metal connectors of the device/cable to become hot during use, and increased the potential of a thermal burn, and 2) this device transmits high energy light.The metal connectors of the fiber optic bunder and the exposed tip may become hot during use.Never lay the device on a patient or on patient drapes." the device history record (dhr) was reviewed, and no abnormalities were noted.A complaint review determined this to be an isolated event for the subject lot.User facility personnel were counseled on the proper use and operation of the fiberoptic retractor and the importance of using the correct cable size.No additional issues have been reported.
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