The urf-v2 video scope, serial number (b)(4) was returned to manufacturer for evaluation due to failing leak test and metal protrusion.The user¿s complaint related to the scope damage was confirmed.The manufacturer performed a visual inspection on the device and found the bending section skeleton protruding out from the bending section cover.The bending section damage was approximately 70 mm from the distal end side, which was also causing a leak on the bending section cover.The bending section cover was removed in order to reveal the extent of the damage to the bending section.Upon removal of the bending section cover, it was confirmed that the bending section skeleton was fully separated producing sharp edges near the insertion tube side.The manufacturer also checked the condition of the bending section support pins, which were not lifted or receding.The instruction manual states the following; ¿do not twist or bend the bending section with your hands.Equipment damage may result¿.The instructions for safe use manual also indicates 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.This is a newer type ns unit (post counter measure) that was verified by the positioning of the bending section tab; in conjunction with the value (2) of the third digit of the serial number, according to the service center repair work aid.Based on the evaluation, the most probable cause of the bending section skeleton breaking was due to excessive force and/or stress from mishandling.
|