Model Number SBT-114-100 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/02/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Block h6: imdrf device code a0413 captures the reportable event of bite blox material separation.
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Event Description
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It was reported to boston scientific corporation that a bite blox was used during an upper gastrointestinal endoscopy performed on (b)(6) 2023.During the procedure, when the endoscope was inserted a snapping sound was heard.A broken piece was found inside the mouth and recovered.There were no oral lacerations.The procedure was completed with another bite blox.There were no patient complication as a result of this event.
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Manufacturer Narrative
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Block h6: imdrf device code a0413 captures the reportable event of bite blox material separation.Block h10: investigation results the returned bite blox was analyzed.Visual evaluation found that the bite blox housing was damaged.A piece of the device in the bite region was broken off, and the presence of bite marks was noted.No other problems were noted.The reported event was confirmed.Product analysis identified that the device had a broken bite piece.It is likely that a compressive bite force caused the bite blox housing to be damaged, as evidenced by the presence of bite marks.Based on all available information and analysis of the returned device, the most probable cause is adverse event related to procedure.
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Event Description
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It was reported to boston scientific corporation that a bite blox was used during an upper gastrointestinal endoscopy performed on (b)(6) 2023.During the procedure, when the endoscope was inserted a snapping sound was heard.A broken piece was found inside the mouth and recovered.There were no oral lacerations.The procedure was completed with another bite blox.There were no patient complication as a result of this event.
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Search Alerts/Recalls
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