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Model Number M00522612 |
Device Problems
Break (1069); 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 03/02/2022 |
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 during a colonoscopy procedure performed on (b)(6) 2022.During the procedure, the clip was retroflexed inside scope and would not deploy when placed on tissue.The scope was then repositioned and the clip eventually fell off.It was reported that the clip was retrieved from the patient and the control wire was broken.The procedure was completed with another resolution clip device there were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
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Manufacturer Narrative
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(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Search Alerts/Recalls
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