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Catalog Number 530.705 |
Device Problems
Noise, Audible (3273); Intermittent Energy Output (4025)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that the battery reamer device had an internal rattle.During an in-house engineering evaluation, it was determined that the device had intermittent operation, foreign substance/debris/cleaning/sterilization, component damage and failed pre-test for general condition.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional narrative: the actual device was returned for evaluation.During evaluation it was determined that the initial reported condition of the device had an internal rattle was not confirmed.Therefore, the assignable root cause was not determined.However, the malfunctions found during service and evaluation have been confirmed.The assignable root cause was determined to be due to improper maintenance.Udi: (b)(4).
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Search Alerts/Recalls
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