|
Model Number M00562651 |
Device Problems
Failure to Deliver Energy (1211); Failure to Cut (2587); Detachment of Device or Device Component (2907)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 07/25/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(6).(b)(4).Investigation results: a sensation large oval med stiff snare was received for analysis.Visual inspection of the returned device revealed that the 2 in 1 connector and the handle cannula was detached.It is most likely that this condition contributed to the failure of delivering energy and this led to difficulties in cutting tissue.No other issues were noted.Since the device has the 2 in 1 connector and the handle cannula detached, these suggest that the assembly process was not performed as per procedure.Based on the information available and the analysis performed, the most probable root cause classification is manufacturing deficiency.A review of the potential causes and controls of the related failure was completed.Based on this review, this complaint does not represent a new or unanticipated event.A labelling review was performed and there was no evidence that the device was used in a manner inconsistent with the labeling or that suggests that there is an issue with the translation, wording, or graphics.There is an investigation in place to address this issue.
|
|
Event Description
|
It was reported to boston scientific corporation that a sensation large oval med stiff snare was prepared for use in the rectum during an endoscopic mucosal resection (emr) procedure on (b)(6), 2019.According to the complainant, when the device entered the cargo inspection channel and inside the patient, the device failed to deliver energy upon opening, so it failed to cut the target polyp.Reportedly, there were no visible issues noted with the cautery pin and the snare was securely attached to the active cord.The procedure was completed with another sensation snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.Note: this event has been deemed an mdr-reportable event based on the investigation results which revealed that the 2 in 1 connector was detached.
|
|
Search Alerts/Recalls
|
|
|