Model Number M00562401 |
Device Problems
Retraction Problem (1536); Failure to Cut (2587)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/01/2020 |
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) 2020 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 failure 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 captiflex medium oval flexible snare was used during a polypectomy procedure performed on an unknown date.According to the complainant, during the procedure, the snare loop failed to retract and did not cut the target polyp.A completely different snare was used to complete the procedure.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block b3: the exact date of the event is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6: problem code 2587 captures the reportable event of snare loop failure 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.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr 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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Event Description
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It was reported to boston scientific corporation that a captiflex medium oval flexible snare was used during a polypectomy procedure performed on an unknown date.According to the complainant, during the procedure, the snare loop failed to retract and did not cut the target polyp.A completely different snare was used to complete the procedure.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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