It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the bands could not be deployed.There was no difficulty experienced upon setting up the device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
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Block h6: device code 2610 for the reportable issue of bands failed to deploy.Block h10: investigation results the returned speedband superview super 7 device and the ligator head were analyzed; however, the handle assembly was not returned.A visual evaluation noted that the tripwire was mechanically cut and it was noticed that the proximal loop was not returned.The distal loop of the trip wire was attached to the suture and was connected to the ligator head.It was possible to observe that the ligator head found six bands attached; however, three bands were moved out of their original positions, showed damages and some sections were torn.It was noted that some of the ligator head teeth were bent.It was also noted that one of the suture ends was ruptured, the knot was out of its position and detached from the ligator head teeth.The suture hole showed stress marks as in white color, and some of the ligator head teeth were bent.No other issues with the device were noted.Based on the evaluation of the returned complaint device, these failures are likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.It is most likely that the ligator head teeth were damaged due to handling and manipulation of the device during the procedure.Once the ligator head teeth are damaged, the suture can be detached from its position on the ligator head and this condition could have generated the bands to moved out of their original positions, impacting the bands deployment activity and could have contributed to the reported issues.There was evidence that the trip wire was cut in order to remove the device from the scope.This condition is not considered as an issue of the device.The reported event was confirmed.This failure is likely due to factors or conditions related to procedure during the use of the device that could have affected its performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu)/product label.
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It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the bands could not be deployed.There was no difficulty experienced upon setting up the device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
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