Model Number M00561241 |
Device Problem
Failure to Deliver Energy (1211)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/02/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The reported health care facility's address is (b)(6).(b)(4).
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Event Description
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It was reported to boston scientific corporation that a captivator ii-20mm round stiff snare was used during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2022.During the procedure and inside the patient, when trying to resect the mucosa the snare could not be energized by high frequency.The snare was securely attached to the active cord but the snare couldn't deliver energy at all.The procedure was completed with the original device by cold polypectomy.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block e1: the reported health care facility's address is (b)(6) prefecture 2320024.Block h6: problem code (b)(6)captures the reportable event of snare could not deliver energy.Block h10: investigation results a captivator ii-20mm round stiff snare was received for analysis.Visual inspection of the returned device revealed no problems had been found.Functional testing was performed, and the loop could extend and retract well.The 2 in 1 connector passed dimensional testing.Electrical testing was performed, and the device was found within specification.No other problems were noted.The reported complaint of device failure to deliver energy was unable to be confirmed since the device passed electrical testing upon return.Device analysis found no problems with the device.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected since the reported complaint cannot be confirmed.
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Event Description
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It was reported to boston scientific corporation that a captivator ii-20mm round stiff snare was used during an endoscopic mucosal resection (emr) procedure performed on (b)(6), 2022.During the procedure and inside the patient, when trying to resect the mucosa the snare could not be energized by high frequency.The snare was securely attached to the active cord but the snare couldn't deliver energy at all.The procedure was completed with the original device by cold polypectomy.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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