|
Model Number M00542251 |
Device Problem
Failure to Fire (2610)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 12/18/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
|
|
Event Description
|
It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during an endoscopic varices ligation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the device failed to deploy an elastic band.The procedure was completed with another speedband superview super 7 device.Additionally, 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 good.
|
|
Manufacturer Narrative
|
Block h6: problem 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 was analyzed.The device returned without the handle assembly and a tripwire.A visual evaluation of the ligator head found seven bands present with four bands were moved out of their original positions.It was noted that one of the bands showed a torn section.Some of the ligator teeth were bent.Additionally, a section of the suture was attached to the ligator head and one knot was observed.The suture was likely cut by a sharp tool and the suture hole showed a stress mark on the white section.It was noticed that some of the ligator head teeth were damaged.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 impacted the bands deployment activity which could have contributed with the reported issues.There was evidence that the suture was cut in order to remove the device from the scope.This condition is not considered as an issue of the device.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.
|
|
Event Description
|
It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during an endoscopic varices ligation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the device failed to deploy an elastic band.The procedure was completed with another speedband superview super 7 device.Additionally, 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 good.
|
|
Search Alerts/Recalls
|
|
|