COOK ENDOSCOPY FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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Catalog Number FS-OMNI-35-260 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/10/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant: erbe electrosurgical generator.Investigation evaluation: our evaluation of the product said to be involved confirmed the report on "difficulty peeling the breakthrough channel".The sphincterotome was returned; however, the wire guide associated with it was not included in the return.A visual examination of the returned sphincterotome showed that the entire breakthrough channel of the catheter has been utilized.Ripples were observed in the catheter of the returned device between approximately 51 cm to 57 cm showing stripping difficulty.No portion of the sphincterotome device is missing.The preloaded wire guide was not included in the return and therefore could not be evaluated.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.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: a corrective action has been initiated to reduce occurrences of stripping difficulty for omni sphincterotomes.The product said to be involved is included in the scope of the corrective actions.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: a corrective action has been initiated in an effort to reduce occurrences of this nature.This product was manufactured prior to implementation of this corrective action.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) procedure, the physician used a cook fusion omni-tome pre-loaded sphincterotome.The breakthrough channel does not peel off correctly.It seems to be difficult to peel off.There was no reportable information at this time.Additional information was received on 10/24/2017.The wire guide breakthrough channel was too difficult to peel off.This ended in losing the wire guide [access] from the bile duct and extending the intervention (anesthesia, time for next patient, etc.).
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