COOK ENDOSCOPY FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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Catalog Number FS-OMNI-35 |
Device Problem
Failure to Align (2522)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/28/2016 |
Event Type
malfunction
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Manufacturer Narrative
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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.The evaluation of the photo provided from the customer shows incorrect orientation of the sphincterotome in the endoscopic view.Without return of the complaint device, further investigation cannot be completed.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.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.Improper cutting wire orientation can occur if the distal end of the catheter is shaped manually.This sphincterotome catheter is precurved and is provided with a precurved stylet in the distal tip of the catheter.This obviates the need for manual formation.The instructions for use contain the following comment: ¿note: do not apply manual pressure to tip or cutting wire of sphincterotome in an attempt to influence orientation, as this may result in damage to device.¿ other factors that can contribute to improper cutting wire orientation include manipulating the handle with the catheter in a coiled position or with the precurved stylet inside the cannulating tip.The instructions for use advise the user to "uncoil and straighten sphincterotome" upon removing the device from the packaging.The user is then instructed to "carefully remove precurved stylet from cannulating tip".The instructions for use contain the following comment: "note: do not exercise handle while device is coiled or precurved stylet is in place, as this may cause damage to sphincterotome and render it inoperable." prior to distribution, all fusion omni-tome pre-loaded sphincterotomes are subjected to a visual inspection and functional test to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: 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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Event Description
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During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion omni-tome pre-loaded sphincterotome.The physician had pre-stripped the sphincterotome "half way down" the catheter before initial insertion of the device into the endoscope channel.When the sphincterotome appeared in endoscopic view, it appeared to be contorted with mis-orientation.The device was new, not previously used and was straight out of the packaging.The physician claims not to have knowingly attempted to rotate the handle or catheter.Upon seeing the mis-orientation of the product, cannulation was not attempted.The user withdrew the device from the endoscope and opened a new fusion omni-tome sphincterotome which when inserted into the endoscope, orientated well.According to the physician, the ercp procedure was then performed without further issue and a good outcome for the patient was achieved.She estimates 10-15 minutes was added to the procedure time because of the need to replace the first device.
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