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Model Number M00550601 |
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 05/26/2021 |
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 alliance inflation syringe was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the mid common bile duct (cbd) on (b)(6) 2021.During preparation, it was noted that the gauge needle would not move when pressure was being applied with the syringe.The procedure was completed with another alliance inflation syringe.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 good.
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Search Alerts/Recalls
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