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Model Number 72205058 |
Device Problems
Optical Discoloration (2999); Optical Problem (3001)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/24/2020 |
Event Type
malfunction
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Event Description
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It was reported that during knee scope procedure, the camera head had a blinking picture and distorted coloring.No delay and a back up device was used to complete the procedure.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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The reported device, used in treatment, was returned to the designated complaint station for independent evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed and no deficiencies were observed.A functional test revealed video flickering when the cable near the camera connector was moved.The complaint was verified and the root cause was associated with component failure.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found related failures; this failure mode will be trended to assess for any necessary corrective actions.
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Search Alerts/Recalls
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