Catalog Number 0502880324 |
Device Problems
Break (1069); Detachment Of Device Component (1104); Component Falling (1105)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/17/2014 |
Event Type
malfunction
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Event Description
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It was reported that the tip broke off and fell inside the patient.
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported that the tip broke off and fell inside the patient.
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Manufacturer Narrative
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The product was returned for investigation.The reported failure mode was confirmed.The unit has a dent on the shaft.Also the ceramic tip is broken and the pieces were not received with the unit.Probable root causes for the broken tip could be the electrode came into contact with the ceramic tip, the ceramic tip was damaged prior to use and/or the bent shaft caused the electrode to come into contact with the ceramic tip.In sum, the product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.
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Search Alerts/Recalls
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