Model Number SBT-114-100 |
Device Problems
Material Separation (1562); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/04/2023 |
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 oral endoscopy performed on (b)(6) 2023.During the procedure, the mouthpiece got bitten strongly by the patient and cracked including the rim part.The endoscope also got bitten and damaged.It was not reported how was the procedure completed.There were no patient complications reported 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 h11: block b5 has been corrected.Block h6 device code has been corrected.
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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 oral endoscopy performed on (b)(6) 2023.During the procedure, the mouthpiece got bitten strongly by the patient and cracked including the rim part.There is a crack in the main body.The endoscope also got bitten and damaged.It was not reported how was the procedure completed.There were no patient complications reported 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.Investigation results: the returned bite blox was analyzed.The visual evaluation found that the bite blox housing was damaged; a large crack was seen and the presence of bite marks.No other problems were noted.The reported event was confirmed.Product analysis identified that the bite blox housing was damaged, a large crack was seen and the presence of bite marks were noted.It is likely that 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 oral endoscopy performed on (b)(6) 2023.During the procedure, the mouthpiece got bitten strongly by the patient and cracked including the rim part.There is a crack in the main body.The endoscope also got bitten and damaged.It was not reported how was the procedure completed.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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