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Model Number M00550600 |
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 07/15/2021 |
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 device was unpacked for an esophagogastroduodenoscopy (egd) procedure performed in the esophagus on (b)(6) 2021.During unpacking, it was noticed that the gauge was broken.Reportedly, the needle would not move regardless of the pressure applied.The procedure was completed with another alliance inflation syringe.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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