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Catalog Number ECHO-19 |
Device Problem
Off-Label Use (1494)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/14/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Pma/510(k) #k092359.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
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Event Description
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Kanno- 'eus-guided biliary drainage for unresectable malignant biliary obstruction: 10-year experience of 99 cases at a single center'.To evaluate clinical outcomes of endoscopic ultrasound (eus)-guided biliary drainage (eus-bd) for unresectable malignant biliary obstruction for cases in which endoscopic retrograde cholangiopancreatography (ercp) failed at a high volume center.Eus-bd was attempted in 99 patients during the study period.75 patients received eus-bd after an ercp attempt and 24 patients underwent eus-bd without an ercp attempt because the papilla was not accessible.After insertion of the echoendoscope (gfuc240p or gf-uct260, olympus co., tokyo, japan), anappropriate route without any vessels was punctured with a 19-gauge needle dedicated for eus-guided fna (echotip).Successful puncture was confirmed through aspiration of bile and contrast injection.Subsequently, a guidewire was advanced toward the liver hilum through the needle.The procedures of eus-bd in relation to stent placement is considered off-label use.
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Manufacturer Narrative
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The rpn of the complaint device has been corrected since the submission of the initial report based on clinical review.The investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.- attachment: [kanno - eus-guided biliary drainage for unresectable malignant biliary obstruction.Pdf].
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Event Description
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Kanno- 'eus-guided biliary drainage for unresectable malignant biliary obstruction: 10-year experience of 99 cases at a single center'.To evaluate clinical outcomes of endoscopic ultrasound (eus)-guided biliary drainage (eus-bd) for unresectable malignant biliary obstruction for cases in which endoscopic retrograde cholangiopancreatography (ercp) failed at a high volume center.Eus-bd was attempted in 99 patients during the study period.75 patients received eus-bd after an ercp attempt and 24 patients underwent eus-bd without an ercp attempt because the papilla was not accessible.After insertion of the echoendoscope (gfuc240p or gf-uct260, olympus co., tokyo, japan), an appropriate route without any vessels was punctured with a 19-gauge needle dedicated for eus-guided fna (echotip).Successful puncture was confirmed through aspiration of bile and contrast injection.Subsequently, a guidewire was advanced toward the liver hilum through the needle.The procedures of eus-bd in relation to stent placement is considered off-label use.
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Manufacturer Narrative
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Device evaluation: the complaint device was not returned therefore a document based review will be performed.Clarification was requested to determine if the device involved was an echo-19 or an echo-hd-19-a device as this was not detailed in the journal article.Reply received as follows; "if a 19-gauge needle dedicated for eus-guided fna, i would presume it is the needle for sample aspiration rather than gaining access." this feedback would indicate that the device involved was echo-19.Document review including ifu review: prior to distribution, all echo-19 devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As the lot number is unknown the device history records could not be reviewed as part of the investigation.The notes section of the instructions for use, ifu0101-1 which accompanies this device instructs the user to; "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".Also, ¿intended use: this device is used to sample targeted submuscosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope.¿ there is evidence to suggest that the customer did not follow the instructions for use (ifu0101-1).Root cause review: a definitive root cause could not be determined from the available information.A possible cause could be attributed to off label use as the echo-19 device is intended to sample targeted submucosal lesions only but was used for gaining access to the gi tract as per journal article (reference section from the journal article "an appropriate route without any vessels was punctured with a 19-gauge needle dedicated for eus-guided fna").Feedback from clinician also stated "if it was an echo-19 device, it would be off-label use as the needle was to sample target lesion rather than gaining an access" summary: complaint is confirmed based on the customer's testimony.According to the initial reporter, the patients did not experience any adverse effects due to this occurrence.
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Event Description
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Kanno- 'eus-guided biliary drainage for unresectable malignant biliary obstruction: 10-year experience of 99 cases at a single center'.To evaluate clinical outcomes of endoscopic ultrasound (eus)-guided biliary drainage (eus-bd) for unresectable malignant biliary obstruction for cases in which endoscopic retrograde cholangiopancreatography (ercp) failed at a high volume center.Eus-bd was attempted in 99 patients during the study period.75 patients received eus-bd after an ercp attempt and 24 patients underwent eus-bd without an ercp attempt because the papilla was not accessible.After insertion of the echoendoscope (gfuc240p or gf-uct260, olympus co., (b)(6), japan), an appropriate route without any vessels was punctured with a 19-gauge needle dedicated for eus-guided fna (echotip).Successful puncture was confirmed through aspiration of bile and contrast injection.Subsequently, a guidewire was advanced toward the liver hilum through the needle.The procedures of eus-bd in relation to stent placement is considered off-label use.
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Search Alerts/Recalls
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