It was reported that after completing the surgery on the patient, the surgeon noticed that the tip of the needle holder was broken.After the surgery, an x-ray examination confirmed that the damaged fragment remained.It will be collected.The broken tip remained in patient and a further surgery to recover the piece is likely.
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The product was not available at kst but could be investigated directly in japan.The following was found: based on the inspection of item 26173kal, it was found that the movable jaw part, which serves as the pivot point for opening and closing the needle holder tip, was damaged.It was also confirmed that there were several traces of damage on the surface other than the gripping surface of the tip lock.The needle was not only clamped on the surface of the gripping surface, but also behind the carbide surface.When the needle is clamped on this surface, the upper and lower clamping surfaces are enlarged, which leads to a load on the pull rod due to leverage forces and thus to damage to the pull rod.The ifu warns against applying excessive force.It is also described in the reprocessing instructions that the article must be checked for damage before each use.Furthermore, the device history records have been checked and found to be according to the specification, valid at the time of production.The event is filed under internal karl storz complaint id: (b)(4).
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