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Model Number C8404 |
Device Problem
Material Separation (1562)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/19/2018 |
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 to manufacturer.A final report will be sent once the results have been analyzed.
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Event Description
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Procedure performed: exploratory laparatomy.The device broke while in the patient's abdomen.The device was replaced.There was no patient injury.It is unknown if the malfunction occurred with the outer or inner ring.Unknown if the sheath tore, broke, or separated.Unknown if the device is available for return.Additional information was received via email from account manager on friday, (b)(6) 2018: don¿t remember the lot number or anything and no need for replacement; all product was removed; happened while it was deployed in the abdomen and immediately noticed since our retraction was lost; we did use handheld rich retractors in addition to the ring.The malfunction was at the sheath, where the sheath connects to the green placement ring.No patient injury.All product was removed.
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Manufacturer Narrative
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The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant¿s experience could not be replicated or confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.
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Event Description
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Procedure performed: exploratory laparatomy.The device broke while in the patient's abdomen.The device was replaced.There was no patient injury.It is unknown if the malfunction occurred with the outer or inner ring.Unknown if the sheath tore, broke, or separated.Unknown if the device is available for return.Additional information was received via email from account manager on friday, 29oct2018: don¿t remember the lot number or anything and no need for replacement; all product was removed; happened while it was deployed in the abdomen and immediately noticed since our retraction was lost; we did use handheld rich retractors in addition to the ring.The malfunction was at the sheath, where the sheath connects to the green placement ring.Patient status: no patient injury.Type of intervention: all product was removed.
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Search Alerts/Recalls
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