Model Number EVO4K220 |
Device Problem
Display or Visual Feedback Problem (1184)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/18/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A follow-up medwatch will be filed as appropriate.Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
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Event Description
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It was reported by the affiliate in china that preoperatively to an unknown procedure, it was observed that the screen showed no video input while preparing for the operation.Another like device was used to complete the surgery.There were no adverse patient consequences reported.No additional information was provided.
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Manufacturer Narrative
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: according to the information received, it was reported that the screen showed no video input as the attached photo shows during the operation preparing (before the operation).It will be repaired in china cts, not return to opco.The complaint device is not being returned, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, the display showed a color bar with no images and it had a message ¿no video input¿.The complaint reported was confirmed.A manufacturing record evaluation was performed for the finished device lot number:0319019c, and no non-conformances were identified.Hands on analysis should provide the evidence necessary to discern root cause.The possible root cause can be associated to connection issues or improper maintenance of the device.However, it cannot be conclusively affirmed.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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Manufacturer Narrative
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additiona narrative: investigation summary: according to the information received, it was reported that the screen showed no video input as the attached photo shows during the operation preparing (before the operation).It will be repaired in china cts, not return to opco.The complaint device is not being returned, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, the display showed a color bar with no images and it had a message ¿no video input¿.The complaint reported was confirmed.A manufacturing record evaluation was performed for the finished device lot number:0319019c, and no non-conformances were identified.Hands on analysis should provide the evidence necessary to discern root cause.The possible root cause can be associated to connection issues or improper maintenance of the device.However, it cannot be conclusively affirmed.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.,the complaint device was received at the service center and evaluated.It was reported that the screen showed no video input as the attached photo shows during the operation preparing (before the operation).Per service manual operational and diagnostic, the reported failure was confirmed.During evaluation, the live video did not have any channels and image was black.After further inspection, it was found that the video capture card (acl tx card) was not being detected; therefore, it was replaced.The repair and testing of the unit was completed per the service manual, bringing the unit back to full functionality.The unit passed all functional tests and is fully operational.The possible root cause for the reported failure could be that the video card have been damaged from a source with electrical intensity not equal to what it can handle.A manufacturing record evaluation was performed for the finished device [0319019c] number, and no non-conformances were identified.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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Search Alerts/Recalls
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