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Model Number M00562672 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/02/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.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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Event Description
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It was reported to boston scientific corporation that a sensation medium oval flexible snare was used during a polypectomy procedure on (b)(6) 2019.According to the complainant, during the procedure, the snare was used to remove the target polyp.They performed a polypectomy and they used a snare to cut the tissue layer.When they were suctioning the polyp through the scope into the trap, a piece of braided metal that is similar to the braided metal of the snare was suctioned up with the polyp.They were concerned that the metal piece was from the snare used, however the snare that they used was still intact.The complainant was unsure where that piece of braided metal came from.The procedure was completed with this device.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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Event Description
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It was reported to boston scientific corporation that a sensation medium oval flexible snare was used during a polypectomy procedure on (b)(6) 2019.According to the complainant, during the procedure, the snare was used to remove the target polyp.They performed a polypectomy and they used a snare to cut the tissue layer.When they were suctioning the polyp through the scope into the trap, a piece of braided metal that is similar to the braided metal of the snare was suctioned up with the polyp.They were concerned that the metal piece was from the snare used, however the snare that they used was still intact.The complainant was unsure where that piece of braided metal came from.The procedure was completed with this device.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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Manufacturer Narrative
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Problem code 2944 captures the reportable event of foreign material present in device.Investigation results: a sensation snare was returned for analysis.Visual evaluation of the returned device revealed that a small piece of wire metal was received with the device.The device was visually inspected, however, no damage was found.Risk analysis was performed on the document polypectomy snares risk management workbook and it was confirmed that the reported event is not a new or unanticipated failure mode and does not require to be updated.Based on the information available and the analysis performed, the most probable root cause for this problem is manufacturing deficiency.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.There is an investigation in place to address this issue.
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Search Alerts/Recalls
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