Model Number M00561221 |
Device Problems
Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/21/2022 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation that a 10mm captivator ii round stiff snare was used during an endoscopic submucosal resection procedure performed on (b)(6) 2022.During the procedure, the active cord connector was disconnected and could not be connected to the snare.The procedure was completed with a similar captivator ii snare.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
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Manufacturer Narrative
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Initial reported city: (b)(6).
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Manufacturer Narrative
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Block e1 (initial reported city) (b)(6) block h11: block b5 was updated to include additional information received on (b)(6) 2022.As there is no reportable allegation against the device itself and there was no serious injury, boston scientific no longer considers this to be a reportable event.
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Event Description
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It was reported to boston scientific corporation that a 10mm captivator ii round stiff snare was used during an endoscopic submucosal resection procedure performed on (b)(6), 2022.During the procedure, the active cord connector was disconnected and could not be connected to the snare.The procedure was completed with a similar captivator ii snare.There were no patient complications reported as a result of this event.*** additional information received on (b)(6), 2022 *** it was reported that the cautery pin is still attached to the snare but would not connect to the active cord.As there is no reportable allegation against the device itself and there was no serious injury, boston scientific no longer considers this to be a reportable event.
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Search Alerts/Recalls
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