Device was returned for evaluation.The returned urf-v2r flexible scope (serial# (b)(4)) was evaluated due to ¿failed the leak test¿ issue.The reported complaint was confirmed.A visual inspection was performed on a received condition and determined that a small portion of the bending section cover is torn, missing and exposing the bending section skeleton.The rest of the bending section cover was removed and determined the bending section skeleton tab was fully broken/detached at the insertion tube area.However, during inspection , there was no significant evidence of sharp edges observed with the broken/detached skeleton.As preventive measure, in the instruction manual it states that ¿do not twist or bend the bending section with your hands.Equipment damage may result; do not insert the insertion tube with excessive force into the ureter or calix.The bending section may be damaged".Additionally, there is also a leak inside the biopsy channel due to tear/torn marks on the channel wall at the distal end side.Based on the evaluation, the likely cause of the bending section skeleton breaking is due to excessive force and/or stress, attributed to mishandling.
|