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Model Number M00566670 |
Device Problem
Display or Visual Feedback Problem (1184)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that an encore 26 inflation device was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the bile duct on (b)(6) 2021.According to the complainant, during preparation, it was noticed that the needle of the gauge did not move when inflating the balloon.The procedure was completed with another encore 26 inflation device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
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Search Alerts/Recalls
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