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Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/12/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Block d4: this is a non-sterile device with no expiration date.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, device manufacture date is unknown.Block h6: imdrf device code a0401 captures the reportable event of brush break.
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Event Description
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Note: this report pertains to one of three hedgehog devices used in the same procedure.It was reported to boston scientific corporation that a hedgehog double-end brush was used during a scope cleaning on (b)(6) 2023.During scope cleaning, the tips of the three brushes came off.The tips were either trapped in the scope and then retrieved or the tips fell off after removal from the scope.There was no patient involvement in this event.No further information has been obtained despite good faith efforts.
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Search Alerts/Recalls
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