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Model Number M00522610 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/14/2022 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation that a resolution clip device was used in the colon during an endoscopic polypectomy procedure performed on (b)(6) 2022.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip could not be deployed and fell off from the biopsy hole during withdrawal of the scope.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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Block h6: medical device code a15 captures the reportable event of clip could not be deployed.Block h10: investigation analysis: the returned resolution clip device was analyzed, and a visual evaluation noted that the device was returned without the clip assembly attached.The clip assembly was returned in a separate bag.Microscopic examination was performed, and it was found that the clip had evidence of both activations performed.Additionally, the yoke was returned detached from the control wire, which is evidence of a proper deployment, and the locking tabs were opened due to normal deployment.No problems with the device were noted.The reported event of clip could not be deployed was not confirmed.The returned device review showed no evidence of either the alleged(s) or any defect which could have contributed to the event.Therefore, the most probable root cause for this complaint is no problem detected.
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Event Description
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It was reported to boston scientific corporation that a resolution clip device was used in the colon during an endoscopic polypectomy procedure performed on (b)(6) 2022.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip could not be deployed and fell off from the biopsy hole during withdrawal of the scope.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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Search Alerts/Recalls
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