The device was returned to service center for an evaluation.A visual inspection was performed on the returned device and found the bending section skeleton protruding out from the section cover.The bending section damage is approximately 70mm from the distal end side, which is also causing a leak.The bending section cover was removed in order to reveal the extent of the damage and confirmed the skeleton is fully separated producing sharp edges near the insertion tube side.Furthermore, service center was discovered that eleven out of the twelve cable support pins on the bending section have receded into the channel causing the pins to lift.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 and this would occur more so in a narrow environment.The scope was previously refurbished (28f) on may 13th 2019.Based on the evaluation, the likely cause of the bending section skeleton breaking is due to excessive force and/or stress, attributed to mishandling.
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The service center received a device for repair as the customer was dissatisfied with the function.Upon estimation, it was noted the bending skeleton is broken and punctured the rubber coating.Additionally, the image had excessive ig breakage.There was no patient injury reported.
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