WILSON-COOK MEDICAL INC FUSION OMNI-TOME; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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Catalog Number FS-OMNI |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/28/2021 |
Event Type
malfunction
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Event Description
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During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook fusion omni-tome pre-loaded sphincterotome.It was initially reported that this tome left a foreign body on the wire [guide] after it was exchanged out of the system.A piece of the device was left on the wire [guide] after it was exchanged out.This caused us to have to remove the wire [guide] to remove the foreign body.Per additional information received on 2/4/2022: there was a ring that was left on the wire [metal band detaches].[subject of report] the metal band detached on the wire [guide] after it was exchanged out and caused the physician to have to remove the wire [guide] to remove the foreign body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Manufacturer Narrative
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Pma/510(k) # k172288.Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.Prior to distribution, all fusion omni-tomes are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: a review of the complaint history was conducted and this represents an unusual occurrence.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
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Search Alerts/Recalls
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