Model Number 8884721237E |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 03/14/2024 |
Event Type
Injury
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Manufacturer Narrative
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An investigation is currently underway.Upon completion, the results will be forwarded.
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Event Description
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The customer reported that the tip of feeding tube was left inside the patient when removed.Per additional information received, the tip was in the oropharynx.After imaging to confirm the presence of the tip, conscious sedation was administered to have it removed using surgical forceps.Injury was limited to the retention of the foreign object which was treated with surgical forceps.No further medical intervention was required.
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Manufacturer Narrative
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Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine a root cause.However, a corrective and preventive action has been initiated to address the reported issue.
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Search Alerts/Recalls
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