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Model Number M0063901020 |
Device Problems
Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/02/2023 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation that a zero tip basket was about to be used during a ureterorenoscopy (urs) procedure performed on (b)(6), 2023.Prior to the procedure, upon checking the basket it was found that the tip was broken and completely detached.The procedure was completed with another zero tip basket device.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 a0401 captures the reportable event of basket wire completely detached from the basket.
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Manufacturer Narrative
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Block h6: imdrf device code a0401 captures the reportable event of basket wire completely detached from the basket.H10: investigation results: the returned zero tip baskets was analyzed, and a visual evaluation noted that the sheath was detached from the handle cannula.The basket wires were in good condition.Functional inspection was not performed due to condition of the device.With all the information available the reported event of basket wire detachment could not be confirmed.Based on the investigation it was found that the sheath is detached from the handle cannula.This could be related to handling and manipulation of the device prior procedure; it is probable that an excess of force applied to the device which could lead to detach the sheath from the handle cannula.Based on the most relevant information of the complaint event description, device analysis and including the product record review results, the device meets all manufacturing specifications, no abnormalities were reported during the assembly process.It was not possible to identify any evidence of the alleged issue.Therefore, the most probable cause of no problem detected was assigned to this investigation.
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Event Description
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It was reported to boston scientific corporation that a zero tip basket was about to be used during a ureterorenoscopy (urs) procedure performed on (b)(6) 2023.Prior to the procedure, upon checking the basket it was found that the tip was broken and completely detached.The procedure was completed with another zero tip basket device.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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