Model Number M00521232 |
Device Problems
Break (1069); Premature Activation (1484); 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 03/10/2023 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation that a resolution 360 clip device was used during an upper endoscopy procedure performed on (b)(6) 2023.During the procedure, the clip was able to close; however, the clip would not deploy.No patient complications have been 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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Block h6: imdrf device code a15 captures the reportable event of clip would not deploy.Block g2: medwatch number is (b)(4).
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Event Description
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It was reported to boston scientific corporation that a resolution 360 clip device was used during an upper endoscopy procedure performed on (b)(6) 2023.During the procedure, the clip was able to close; however, the clip would not deploy.No patient complications have been reported as a result of this event.No further information has been obtained despite good faith efforts.Additional information received on april 6, 2023: it was reported that the resolution 360 clip was used in the stomach during an esophagogastroduodenoscopy (egd) procedure.Additionally, it was clarified that the clip did not close onto tissue instead the clip deployed before being opened.It was suspected that the wire was broken.The procedure was completed with a non-bsc device.There were no patient complications have been reported due to this event.
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Manufacturer Narrative
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Block g2: medwatch number is 2600320000-2023-8051 block h2: additional information: block a2 (patient age), b5 (describe event or problem), b7 (other relevant history) and h6 (device codes and impact codes) have been updated based on the additional information received on april 6, 2023.Block h11: correction: block h6 imdrf device code has been updated to a150103 to capture that this event will no longer be reportable.
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Search Alerts/Recalls
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