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Model Number M00542250 |
Device Problems
Failure to Fire (2610); Device Misassembled During Manufacturing /Shipping (2912)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/08/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during a band ligation procedure performed on (b)(6) 2021.During the procedure, the first band would not come off the ligator cap.It was suspected that this could possibly be due to the wrong order of threads installed.It was noted that 3 to 4 threads are "pulling".The procedure was completed with another speedband superview super 7 device.There was no difficulty experienced upon setting up the device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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Search Alerts/Recalls
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