Device evaluated by mfr: the device was returned for evaluation.The accustick device was returned and it was observed that the ro marker was out of its location in the device middle section since it moves freely.Additionally, the accustick device was bent and had the distal tip was broken.No more damages were observed.The device was inspected under microscope and it was observed that the distal tip was broken, this damage is located next to the ro marker position.It's important to mention that evidence of correct ro marker colocation was observed at device distal end section.The device was measured in order to confirm the ro marker position; and the ro marker was located approximately at 3.5cm from the distal tip, and the specification is: 6.50mm0.50mm.The ro market was measured by outer diameter and the results were 0.0823in, and the specification is: 0.08200.0005.No other issues were identified during the product analysis.
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