It was reported that after a therapeutic greenlight laser vaporization procedure, prior to reprocessing, the device tip was found damaged and fell off.It is believed that the damage was caused by the greenlight laser light hitting the tip.There was no patient harm or injury reported due to the event.No user injury reported.
|
This supplemental report is being submitted to provide review of the device history records (dhr) and investigation conclusion.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Laser damage to the distal tip is a known phenomenon that may occur from direct or reflected energy by misfiring of laser.As stated on the ifu (instruction for use) and as a preventive measure, the user manual states: keep the distal tip of any electrode, probe, laser fiber, or other ancillary device in the field of view at all times when active.In addition, as a ceramic material is brittle in nature, all ceramic tips are susceptible to fracture even though more robust re-design has been implemented.The ifu alerts the risk of ceramic tip damage that "damage may result in the loss of the entire ceramic tip or fragments of the ceramic tip.If there is evidence of charring, burn spots, chips or cracks in the ceramic tip or surrounding area, do not use.Olympus will continue to monitor complaints for this device.
|