Catalog Number 0375940000 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/30/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Mfg date: the device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.Gtin: (b)(4).
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Event Description
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It was reported that the shaver blade broke off in the patient during use.It was retrived from the patient and the case was completed susccessfully.
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Manufacturer Narrative
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Through investigation it was noticed that the break was at the hub of the device.The bur breaking at the hub would cause the burs to be unusable but will not cause harm to the patient.The procedure was completed successfully with no medical intervention or adverse consequences.There is no information to suggest that a recurrence would result in injury.Therefore this event description is not fileable.Updated rationale from malfunction to no report required.
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Event Description
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It was reported that the shaver blade broke off in the patient during use.It was retrieved from the patient and the case was completed successfully.
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Search Alerts/Recalls
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