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Model Number 133650 |
Device Problems
Mechanical Problem (1384); Material Deformation (2976); Mechanics Altered (2984)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, on an ent procedure, during the ligation of the tissue or vessel, the clips did not close all the way, were crossing, and were falling off the jaws.Another device was used to complete the case.There was no patient injury.
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Manufacturer Narrative
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Evaluation summary: post market vigilance (pmv) led an evaluation of one photo and four devices.A visual inspection of the returned photo noted: the photo depicts two clips, one unformed, and one what appears to be partially formed.The first instrument was received partially applied with two remaining clips.The second instrument was received partially applied with eighteen remaining clips.The third instrument was received partially applied with five remaining clips.The fourth instrument was received fully applied.Visual inspections of the four instruments revealed no abnormalities.Functionally, the first three instruments were fired once in air and proper clip formations were confirmed.The remaining clips were then fired on test media with proper formation.The jaws and handles moved smoothly through their firing cycles and returned to the open positions and each remaining clip loaded properly in the jaws.When the cartridges were empty, the interlocks engaged and prevented the jaw from approximating.The fourth instruments empty cartridge precludes firing evaluation; however, the interlock was engaged and properly prevented the jaw from approximating.Note that the information for use brochure which accompanies each product shipment cautions the user as follows: ensure that the handles are squeezed together firmly as far as they will go.Failure to squeeze the handles completely can result in clip malformation and possible bleeding or leakage.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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