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Model Number M00562673 |
Device Problems
Failure to Cut (2587); Difficult to Open or Close (2921)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The exact date of the event is unknown.The provided event date of (b)(6) 2021 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(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 medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that a sensation medium oval flexible snare was used during a colonoscopy procedure performed on an unknown date.During the procedure, the snare made clicking sounds when extending and retracting and it seemed difficult to move.In addition, the snare was experiencing extreme difficulty with cold snaring a 3-5 mm target polyp and also with hot snaring.It was noted that it was almost tearing the tissue.The procedure was completed with another sensation snare.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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