Model Number 174007 |
Device Problems
Component or Accessory Incompatibility (2897); Expulsion (2933); Mechanical Jam (2983)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/06/2019 |
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 laparoscopic hernia repair, the two staplers and two loading units had jammed.New stapler was opened and used to complete 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 device.Visual inspection and functional testing confirmed there were no abnormalities that would have caused or contributed to the reported condition.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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Event Description
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According to the reporter, during laparoscopic hernia repair, the two staplers and two loading units had jammed.The surgeon was not able to load the clip prior to firing.The device was pulled out of patient to examine the jaws to notice a crimped clip lodged in jaws that wasn¿t advancing forward.He was able to shack it out on the back table.A new stapler was opened and used to complete case.There was no patient injury.
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Search Alerts/Recalls
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