The mr-6la device has not been returned to olympus for evaluation.The cause of the reported complaint cannot be confirmed.To mitigate against patient injury during use, the device instructions for use document contains several warning statements regarding device operation.Prior to the procedure, ¿check the outer surface of the shaft prior to each use to make certain that the instrument is free of any cuts, holes, rough surfaces, sharp edges, or protrusions.Do not use if damage is suspected or discovered.¿ during the procedure, ¿avoid using excessive torque/force on the endoscope, as patient injury and possible damage to the instrument could result.¿ ¿keep the distal tip of any electrode, probe, laser fiber or other ancillary device in the field of view at all times when active.¿ and ¿caution: undue stress on the endoscope shaft may cause bending or breaking.If the distal shaft is bent due to the rigors of a difficult procedure, do not attempt to straighten it; damage can result.¿ as a preventive measure in the event of device malfunction, the instructions for use document also recommends ¿due to the high fragility of flexible endoscopes, always have a backup scope available.¿.
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Two of 2.Olympus was informed that during a diagnostic ureteroscopy, the surgeon was having trouble accessing the left distal ureter using another ureteroscope device.The other ureteroscope was removed from the patient and the mr-6la long rigid ureteroscope was substituted.While using mr-6la ureteroscope, the surgeon noticed that the ureter had detached from the kidney.Afterwards the patient was informed that a separate laparoscopic intervention is indicated to repair the avulsed ureter.
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