Model Number 1883519HR |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/09/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Analysis results were not available as of the date of this report. a follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.
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Event Description
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A healthcare professional (hcp) reported that the blade was broken/damaged on normal use during the endoscopic sinus surgery.There were no broken pieces remain inside the patient's body.The product was used for the first time and the procedure was completed with a back up product.There was no intervention planned or performed.There was no delay with the procedure.There was no patient impact.
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Manufacturer Narrative
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Analysis found that there was a residue consistent with biological contaminants on the device.The inner assembly pulled out freely and visually, the spiral wrap broke at the proximal end that would have resulted in the reported event.The break point showed the spiral wrap was twisted in on itself in a clockwise direction which is consistent with excess torsional load.The inner tip moved freely therefore it was not the source of the torsional load.The middle assembly spun freely by hand.The distal side of the locking area on the rotating hub was deformed in such a way that indicates bending or prying the blade while in the handpiece.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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