Model Number SBC-501-100 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/06/2021 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation that a seal biopsy valve was used during a colonoscopy procedure performed on (b)(6) 2021.During the procedure, when a radial jaw biopsy forceps was passed down the biopsy channel, a piece of the biopsy cap detached and travelled down the scope.It was noted that no fragmented material of the biopsy cap fell inside the patient's body.The procedure was completed with another seal biopsy cap.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that a seal biopsy valve was used during a colonoscopy procedure performed on october 06 2021.During the procedure, when a radial jaw biopsy forceps was passed down the biopsy channel, a piece of the biopsy cap detached and travelled down the scope.It was noted that no fragmented material of the biopsy cap fell inside the patient's body.The procedure was completed with another seal biopsy cap.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block h6: device problem code a040103 captures the reportable event of device material fragmentation.Block h10: the device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Search Alerts/Recalls
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