Model Number M00562451 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/15/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported to boston scientific corporation that a captivator small hexagonal stiff snare was prepared for use to remove polyps in the colon during an endoscopic colorectal polypectomy procedure performed on (b)(6) 2022.During preparation and outside the patient, the cautery pin was loose/disconnected.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block h6: medical device code a0501 captures the reportable event of cautery pin detached.Block h10: (product investigation) one captivator snare was received for analysis.Visual inspection of the returned device found no problems.The 2 in 1 connector did not have any problems.Microscopic test of the 2 in 1 connector found no damages.No other problems with the device were noted.The reported event of "cautery pin detached" could not be confirmed since no problems were noted with the 2 in 1 connector during visual and microscopic test.Based on the analysis of the returned device and the information available, the code selected as the most probable cause is no problem detected.
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Event Description
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It was reported to boston scientific corporation that a captivator small hexagonal stiff snare was prepared for use to remove polyps in the colon during an endoscopic colorectal polypectomy procedure performed on (b)(6) 2022.During preparation and outside the patient, the cautery pin was loose/disconnected.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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