Pentax medical became aware of a report for an event which occurred in the united states stating, " elevator broken.No angulation" involving pentax model eg-3870utk, serial number (b)(4).The timing and location of the observance is unknown.Additional information has been requested but has not been provided.The customer owned endoscope has not been received by pentax medical for evaluation under (b)(4) as of 03-sep-2021.Model eg-3870utk, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service.The investigation is in-process.
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Evaluation summary: customer reported elevator broken (no angulation).Therefore, we checked the returned unit and confirmed that the deflector body loosened.Based on the result, we concluded that it was caused due to the excessive force applied on the deflector body.In addition, we confirmed that the eog valve broken, the lg cable connector scratched, the deflector operating knob grinding, and the body cover grip scratched; however, they are not the main cause, and/or irrelevant to the alleged complaint.
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