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Model Number GIA8038S |
Device Problems
Failure to Advance (2524); Misfire (2532)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/09/2018 |
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, during a cystectomy/ileal conduit, the surgeon started firing the device, however preset cartridge did not advance on the halfway.Replaced by new cartridge, the same event occurred.They replaced the handle and firing was successful.
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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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Manufacturer Narrative
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Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the instrument noted that the center bar had retracted in the retainer.The loading unit displayed a full complement of staples and the interlock was set.No damage was noted to the knife blade.The single used loading unit(sulu) was loaded into a test unit.The test instrument and sulu were applied to the appropriate test media with acceptable results.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the center bar retraction condition may occur if the loading units are unloaded improperly.After firing, if the firing knob is not fully retracted, difficulty in removal of the loading unit may be experienced and the center bar may fall back into the firing knob retainer.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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