No serious injury occurred and no known impact or consequence to the doctor involved.However, nidek incorporated considers this issue a reportable event as the device had malfunctioned and has a potential to cause or contribute to a serious injury if the malfunction were to recur.Nidek hired third party ((b)(4)) to perform the correction as per recall (z-1245-2016).At this time, device evaluation anticipated but has not begun.Therefore, a follow-up will be submitted once the evaluation is completed.
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On (b)(4) 2017, during a recall process, a nidek incorporated recall coordinator received information from a customer that the near point chart rod on their rt-5100 serial #(b)(4)fell several times and had hit her and another doctor on the head on multiple occasions.The complainant claimed that it did hurt for a bit but no bruise or no serious injury occurred, and thereby, medical treatment/intervention was unnecessary.
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