COOK ENDOSCOPY FUSION OMNI-TOME; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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Catalog Number FS-OMNI |
Device Problems
Failure to Align (2522); Malposition of Device (2616)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter occupation: unknown.The investigation is on-going.A follow-up emdr will be provided.
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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.The physician detected the cutting wire did not align with the device [orientation issue].Another fs-omni was used to complete the procedure.A section of the device did not remain inside the patient¿s 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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Initial reporter occupation: unknown.Investigation evaluation: an evaluation of the device confirmed the report of incorrect cutting wire orientation.During our laboratory analysis, the sphincterotome was advanced through a duodenoscope that was placed in a simulated biliary position.The duodenoscope has an accessory channel that is 4.2 mm in diameter (olympus model number tjf-160v).The catheter exited the endoscope with the cutting wire facing 10 o¿clock.The distal end was then advanced into the simulated papilla and was attempted to be bowed and the cutting wire was facing 8 o'clock (appropriate orientation is approximately 11:00 - 1:00 o'clock).The device failed to bow, a visual inspection it was determined that there was a breakage at the center cannula and a complete functional test could not be performed.The sphincterotome catheter was subjected to a close visual examination and twisting of the tubing was observed at the distal end.The cutting wire was also observed to be bent.A discrepancy or anomaly that could have contributed to the reported event was not observed during our laboratory analysis of the returned product.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 definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.A factor that can contribute to improper cutting wire orientation includes 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: "upon removing device from package, uncoil and straighten sphincterotome." 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 sphincterotomes are subjected to a visual inspection and functional testing 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) procedure, the physician used a cook fusion omni-tome sphincterotome (fs-omni).The physician detected the cutting wire did not align with the device [incorrect cutting wire orientation].Another fs-omni was used to complete the procedure.A section of the device did not remain inside the patient¿s 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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