Model Number 1884004 |
Device Problems
Break (1069); Material Fragmentation (1261)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/17/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The blade has not been returned for evaluation.A product analysis has not been performed.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The customer reported that during a procedure, the surgeon indicated the blade was not working.When he took the blade out of the patient to examine the blade, the tip of the blade had broken off.The nurse saw the tip on the endoscope monitor and retrieved the tip of the blade.There was no patient injury.
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Manufacturer Narrative
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Product analysis indicates one opened sample, part number 1884002, from lot number [no information] was received.There was a residue consistent with biological contaminants on the device.Although the reported part number was 1884004, the configuration of the device is consistent with the part number as stated above.The distal tip had broken off the inner cutter which would have resulted in the reported event [the tip of the blade had broken off].The portion that became detached measured approximately 0.25¿ in length.The break occurred at the first proximal tooth valley.There was uneven wear at the cutting tip which may indicate an interference fit between the inner and outer assemblies at the tip.There was an out of specification condition identified as it relates to the complaint.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The device lot is not available as the package was discarded.A fess (functional endoscopic sinus surgery) was performed.Using the scope, the surgeon was able to identify the fragment and retrieved the fragment.
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Search Alerts/Recalls
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