This supplemental report was submitted to provide additional information to mdr# 1037007-2020-00030.The device was not returned for a physical inspection.The original equipment manufacturer (oem) performed a device history record review for product with lot # pr868415 and no abnormalities were noted.An investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The root cause could not be determined as the device was not returned for inspection.However, based on follow-up communication with the medical facility personnel, it was noted that "he [surgeon] hit it with a laser and it sparked.The nitinol portion of the prothesis vaporized".This suggests that a laser was used to heat the piston.Per the instructions for use, a low temperature heating device should be used to activate the crimp.By the use of a low temperature (65° c) heating device.Once the loops have been placed around the incus or malleus, the low temperature heating device may be positioned so that the tip is in near proximity to the loops on the incus or malleus.At a distance of.5 mm to 1 mm, the heat generated by the low temperature heating device is sufficient to activate the closing of the wire loops.By touching the tip of a bipolar cautery to the wire loops and applying electrical energy of approximately 10 watts.Heat energy transfer occurs best when the incus or malleus is first moistened with a few drops of saline.A setting of greater than 10 watts for the bipolar cautery increases the likelihood that damage to the surrounding mucosa may occur.Precautions: care should be taken.Olympus will continue to monitor the field performance of this device.
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