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Model Number M00542251 |
Device Problems
Premature Activation (1484); Component Missing (2306); Failure to Fire (2610)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/27/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(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.
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Event Description
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It was reported to boston scientific corporation that a speedband superview super 7 device was used during an esophageal variceal ligation (evl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that there were only five bands present on the ligator cap.Reportedly, the physician adjusted the spool; however, two bands deployed together.Then, the device was attempted to be deployed, but elastic bands would not release.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 stable.
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Manufacturer Narrative
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Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6: problem code 2610 captures the reportable issue of bands failed to deploy.Problem code 1484 captures the reportable issue of bands prematurely deployed.Block h10: investigation results the returned speedband superview super 7 and the ligator head were analyzed.A visual evaluation noted that the tripwire was completely removed out of the handle and was attached to the ligator head.It was possible to observe that there were three bands present on the ligator head, and attached in their original positions; however, four knots were found on the suture, indicating that the rest of the bands were successfully deployed.It was also noticed that the ligator teeth did not present any visual damage.No issues were observed on the suture hole and the handle assembly did not present any visible damage.A functional evaluation was performed by rotating the handle knob 180 degrees, an audible click was heard and indents were felt.No other issues with the device were noted.The reported event was not confirmed.Based on the evaluation of the returned device, no failures were found that could have reduced the performance of the device during the procedure.The returned device review showed no evidence of either the alleged(s) or any defect which could have contributed to the event.Therefore, the most probable root cause for this complaint is no problem detected.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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Event Description
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It was reported to boston scientific corporation that a speedband superview super 7 device was used during an esophageal variceal ligation (evl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that there were only five bands present on the ligator cap.Reportedly, the physician adjusted the spool; however, two bands deployed together.Then, the device was attempted to be deployed, but elastic bands would not release.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 stable.
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Search Alerts/Recalls
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