Catalog Number 07.02117.001 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Without a product return, no product evaluation is able to be conducted.The lot number is unknown.Therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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Event Description
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It was reported that the tip of a vitality ball tip probe fractured intra-operatively.The fractured tip was recovered from the patient.There were no reported patient impacts.
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Manufacturer Narrative
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Additional information in h6: component, investigation type, findings, and conclusions.Inspection: the device was not returned and no photos were provided, so an evaluation is unable to be performed.Dhr review: the lot number was not provided, so the dhr was unable to be reviewed.Potential root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.This event could also be attributed to off-axis forces applied during use.Device usage: this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.
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Event Description
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It was reported that the tip of a vitality ball tip probe fractured intra-operatively.The fractured tip was recovered from the patient.There were no reported patient impacts.
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Search Alerts/Recalls
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