The device in question was returned for analysis.A visual inspection of the scope noted the bending section skeleton tab is protruding (sticking out) from the bending section cover near the insertion tube area.This particular section of the bending section cover is also missing a small portion (approximately 10%) that was not returned for evaluation.The bending section cover was removed and the bending section skeleton was found to be fully broken and separated, with no signs of any sharp edges.The skeleton tab that was protruding from the bending section cover is bent.The device was serviced and returned to the user facility.Further finding¿s include; excessive broken fibers (black dots) throughout the image, and a biopsy channel leak.Based on the evaluation, the likely cause of the bending section skeleton breaking is due to excessive force and/or stress, attributed to mishandling.The instruction manual states the following; ¿do not twist or bend the bending section with your hands¿.Additionally, the instructions manual for safe use indicate that, "damage to the bending section would happen if excessive force was applied while angulating in the opposite direction if there was no movement from the bending section; this would occur more so in a narrow environment." based on the investigation, the cause of the broken bending section skeleton and bent skeleton tab is most likely due to excessive force and/or stress attributed to user mishandling.If additional information becomes available, a supplemental report will be submitted.
|