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 09/29/2022 |
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 duodenal ampulla during a gastroscopy procedure performed on (b)(6) 2022.During the procedure, the clip could not be deployed smoothly.After repeatedly advancing and withdrawing the device, the clip eventually deployed.The procedure was completed with same original resolution clip.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Initial reporter healthcare facility: (b)(6).(b)(4).
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Manufacturer Narrative
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Block e1: initial reporter healthcare facility: guili(b)(6) hospital.Block h2: additional information: block a1 (patient identifier), a4 (patient weight) and b5 (describe event or problem) have been updated based on the additional information received on january 16, 2023.Block h6: imdrf device code a15 captures the reportable event of clip difficult to release from catheter.Block h11: correction: block g2 (report source).
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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 duodenal ampulla during a gastroscopy procedure performed on (b)(6) 2022.During the procedure, the clip could not be deployed smoothly.After repeatedly advancing and withdrawing the device, the clip eventually deployed.The procedure was completed with same original resolution clip.There were no patient complications reported as a result of this event.Additional information received on january 16, 2023: it was clarified that the procedure was completed with another resolution clip.
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Search Alerts/Recalls
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