COOK ENDOSCOPY ACROBAT® 2 CALIBRATED TIP WIRE GUIDE; OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
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Catalog Number AWG2-35-260 |
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 Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: cook fusion omni-tome sphincterotome, fs-omni, cook fusion wire guide locking device, fs-wl-p-s.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.Instructions for use state the following: "flush endoscope accessory channel and/or lumen of device with sterile water, then insert wire guide floppy end first.Note: for best results, wire guide should be kept wet." prior to distribution, all acrobat 2 calibrated tip wire guides are subjected to a visual inspection to ensure device integrity.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 acrobat 2 calibrated tip wire guide.The sphincterotome, cook fusion omni-tome, did not strip at all during exchange.The sphincterotome material was stripping with a zig zag pattern, and thin strips of plastic were coming away.Exchanging [the accessory device] was impossible.Wire guide access was lost (subject of this report).
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Search Alerts/Recalls
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