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Model Number C4121 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problems
Tissue Damage (2104); No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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No product is being returned for evaluation and no lot # has been provided.A follow-up report will be sent once the results have been analyzed.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.
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Event Description
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Omega loop / gastric bypass: "cer created because rep mentioned" doctor "has experienced more than 5 instances where the grasper has caused a bowel injury when performing a gastric bypass." intervention: "unk".Patient status: "unk".
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Manufacturer Narrative
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The event unit was not returned to applied medical for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the event.Although the exact root cause of the event could not be determined, applied medical has opened a corrective and preventative action report to further elevate and track this investigation and implement appropriate corrective actions, where applicable, to mitigate this type of event.
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Search Alerts/Recalls
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