Catalog Number C-CAE-14.0-70-FIC-SPOPS |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Catalog # c-cae-14.0-70-fic-spops.Awaits product to be returned.Investigation is still in progress.
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Event Description
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Description of event according to complainant: the frova has a significant bend in it and the doctor was unable to pass the ett over the frova to intubate the patient.The frova had to be removed and another bougie placed to be able to intubate patient.Patient outcome: no part of the device remained inside the patient the patient did not require any additional procedures due to this occurrence, but an additional device had to be used during the procedure.No adverse effect to the patient.
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Manufacturer Narrative
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(b)(4).Catalog # c-cae-14.0-70-fic-spops.Awaits product to be returned.Summary of investigational findings: no imaging was provided, but an investigation of the returned frova catheter revealed a minor kink approx.21cm from proximal end.It cannot be determined exactly how or when in time it was kinked, or if this small kink caused enough of a problem to prevent ett migration.Many variables can lead to a failed intubation, but since only very limited information was provided, it is not possible to determine, if the kink contributed to the difficulties encountered when attempting to intubate the patient.It should be noted, that the patient did not require any additional procedures.There is no evidence to suggest the product was not manufactured according to specifications.Cook medical will continue to monitor for similar events.
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Event Description
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Description of event according to complainant: the frova has a significant bend in it and the doctor was unable to pass the ett over the frova to intubate the patient.The frova had to be removed and another bougie placed to be able to intubate patient.Patient outcome: no part of the device remained inside the patient.The patient did not require any additional procedures due to this occurrence, but an additional device had to be used during the procedure.No adverse effect to the patient.
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Search Alerts/Recalls
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