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Catalog Number 72202959 |
Device Problem
Optical Problem (3001)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/25/2020 |
Event Type
malfunction
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Event Description
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It was reported that, during surgery, the "4mm x 30° hd video arthroscope" did not have a clear image.The procedure was successfully completed without delay using a back-up device.No patient injuries or 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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H10: further assessment of information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The information states that no harm nor injury was reported and no previous injury or harm has been confirmed to be caused by the device in the past, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
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Search Alerts/Recalls
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