Model Number M00562402 |
Device Problem
Entrapment of Device (1212)
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Patient Problem
Tissue Damage (2104)
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Event Date 06/29/2020 |
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 failure 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 captiflex medium oval flexible snare was used during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the tissue was torn.Another captiflex 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 h6: problem code 1212 captures the reportable event of snare loop embedded in patient's tissue.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 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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Event Description
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It was reported to boston scientific corporation that a captiflex medium oval flexible snare was used during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the tissue was torn.Another captiflex 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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