Catalog Number 0250080767 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/15/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.(b)(4).Mfg date: the device manufacture date is not known at this time.
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Event Description
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It was reported that the grasper is snapping at the joint of the grasper.Although there was patient involvement, there was no adverse consequence.
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Manufacturer Narrative
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(b)(4).Mfg date: the device manufacture date is not known.Alleged failure: graspers are snapping at the joint of the grasper.At that point, there is no control of the instrument from the handle.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be excessive force, or rotational force with the jaw under load.The product was returned for investigation and the failure mode was confirmed and will be monitored for future reoccurrence.
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Event Description
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It was reported that the grasper is snapping at the joint of the grasper.Although there was patient involvement, there was no adverse consequence.
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Search Alerts/Recalls
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