Model Number 1884005HRE |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/27/2016 |
Event Type
malfunction
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Manufacturer Narrative
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When compared to the assembly drawing: visually, the tip of the inner cutter broke off which would have resulted in the reported event.The tip measured approximately 0.22 long.The break points correspond to the first proximal valley of the inner blade teeth.There were no signs of excess pressure being applied during use or improper loading of the blades into the handpiece.The deformation of the breaks is consistent with the inner tip contacting the outer tip during use.For this break to occur, the tip(s) configuration would have had to be or become deformed.One of the most likely causes is "aggressive use-case/handling condition with a part that has a thinner than expected wall thickness area where the breaks are occurring".A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the tip of the blade broke off during use.There was no patient impact.
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Manufacturer Narrative
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Age at time of event: (b)(6) sex: male, weight: (b)(6).Date of this event: (b)(6) 2016.Date of this report: (b)(6) 2016.Describe event or problem: additional information: the tip broke inside the patient's nasal cavity.It was retrieved by the surgeon.There was no patient injury.Rpt.Sent to fda? yes medwatch received for this event: (b)(6).Date manufacturer received: 11/16/2016.
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Event Description
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Additional information: the tip broke inside the patient's nasal cavity.It was retrieved by the surgeon.There was no patient injury.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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