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Model Number 2261 |
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 06/01/2022 |
Event Type
malfunction
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Event Description
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This report pertains to the first of three resolution 360 clip devices used in the same patient and procedure.It was reported to boston scientific corporation that three resolution 360 clip devices were used during a colonoscopy procedure performed on (b)(6) 2022.During the procedure, three clips would not deploy after being closed and positioned.It was noted that the scoped was not torqued and nothing seemed wrong.Additionally, the wire felt too stiff and flimsy at the same time.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.
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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 failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.No product returned.
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Search Alerts/Recalls
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