Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Device report from synthes mitek reports an event in (b)(6) as follows: it was reported by the affiliate via cst that after the pure view system was switched on and the camera inserted, the camera head ac - c-mount could not display a visual- merely horizontal, flickering stripes on black background were visible (and configuration instruction + image counter).After switching the processor (ccs) off and on again, also cleaning the camera connector with 70%alcoholic wipes and dry off, the system was working again.No additional information provided.This complaint is for one (1) camera head ac - c-mount.This report is 1 of 1 for (b)(4).
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: additional information: investigation summary = > according to the information provided, it was reported that after the purevuew system was switched on and the camera inserted, the camera head ac - c-mount could not display a visual- merely horizontal, flickering stripes on black background were visible (and configuration instruction + image counter).The complaint device is not being returned, it was not available by the customer, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, the observations reveal the camera was not display a visual image.Besides, the screen had an interference since stripes horizontal on black background were observed.The complaint reported was confirmed.The photo do not provide enough evidence to determine root cause.The possible root cause can be associated to connection issues or may be related to the lack maintenance; however, it cannot be conclusively affirmed.Hands on analysis should provide the evidence necessary to confirm the root cause.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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