Model Number M00562402 |
Device Problems
Failure to Cut (2587); Defective Device (2588); Difficult to Open or Close (2921)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/26/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, 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 captiflex medium oval flexible snare was used in the colon during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, the snare was not cutting through properly and was exhibiting little to no resistance when attempting to cut.This was happening with both hot and cold polypectomy.The snare was not providing a clean and smooth resection of polyps.They tried opening and closing the snare and tried it in hot and cold polypectomy.They also double checked the connection and cautery settings.Reportedly, they visually identified that the catheter seemed shorter when looking at the distal tip.The procedure was completed with another captiflex snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be fine and stable.
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Event Description
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It was reported to boston scientific corporation that a captiflex medium oval flexible snare was used in the colon during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, the snare was not cutting through properly and was exhibiting little to no resistance when attempting to cut.This was happening with both hot and cold polypectomy.The snare was not providing a clean and smooth resection of polyps.They tried opening and closing the snare and tried it in hot and cold polypectomy.They also double checked the connection and cautery settings.Reportedly, they visually identified that the catheter seemed shorter when looking at the distal tip.The procedure was completed with another captiflex snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be fine and stable.
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Manufacturer Narrative
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Block h6: problem code 2587 captures the reportable event of snare loop failed to cut.Conclusion code 4316 is being used in lieu of an adequate conclusion code for "device not returned." block h10: the device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: blocks h2, h6 and h10 have been updated based on the investigation closure for device not returned.Correction: sections h7 and h9.
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Search Alerts/Recalls
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