The device was returned to pentax for further evaluation on service order (b)(4) where the user narrative was not confirmed.The inspection findings are as follows: passed dry leak test, air/ water nozzle glue missing, bending rubber glue cracking at insertion tube side, customer complaint not duplicated, distal body chipped, passed wet leak test the device was repaired where all defects found was remediated and return to the user on delivery (b)(4).If additional information becomes available, a supplemental report will be filed with the new information.
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Evaluation summary: customer reported primary channel blocked.The customer stated unknown object in channel.However, there was no repair data that could determine the cause.We checked the returned unit and confirmed that the air/water nozzle missing.Based on the result, we concluded that it was caused due to the physical damage applied on the air/water nozzle.Correction information: g6: follow up #1, h2: type of follow up.H6: coding changed based on the investigation result.Additional information: h4: device manufacture date.
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