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Catalog Number ECL-18X5.5 |
Device Problem
Fracture (1260)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/05/2015 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: inflation device (unknown type), cook metii-035 wire guide.The event is still currently under investigation.Once the investigation is completed, a follow up report will be sent to reflect our findings.
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Event Description
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During a stricture dilation procedure, the physician used a cook eclipse ttc wire guided balloon dilator.While inserting the lubricated balloon catheter, the catheter got stuck in the scope accessory channel and further attempt [when further attempt was made to advance through the scope], catheter breakage [the catheter broke] and failure to advance it through endoscope channel.On 01/13/2016, additional information was received that the sheath detached inside of the endoscope.
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Event Description
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This follow up report is being sent to cancel the initial report submitted relating to this event because additional information was provided.Please reference the following sections for justification: description of event and patient outcome.During a stricture dilation procedure, the physician used a cook eclipse ttc wire guided balloon dilator.While inserting the lubricated balloon catheter, the catheter got stuck in the scope accessory channel and further attempt [when further attempt was made to advance through the scope], catheter breakage [the catheter broke] and failure to advance it through endoscope channel.On 01/11/2016, the device was returned for evaluation.Upon initial evaluation, it was discovered that the coil spring had detached from the stylet.The coil spring was not included with the return of the device.It was later confirmed that the coil spring was not located in the endoscope either.On 01/13/2016, additional information was received that the sheath detached inside of the endoscope.On 01/19/2016, additional information was received that the additional procedures of the laparotomy and colon resection were performed due to physician preference as the physician is a surgeon.
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Search Alerts/Recalls
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