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Catalog Number 530.730 |
Device Problems
Difficult To Position (1467); Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/13/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that during an unspecified surgical procedure, it was observed that the chuck device would not close and did not grab on to the instrument.There were no delays in the surgical procedure and a spare device was available for use.It was reported that the surgery was completed successfully.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.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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The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the device passed all manufacturing specifications and identified no failure.Therefore, the reported condition was not confirmed and an assignable root cause was not determined.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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